A COMPARISON OF PAIN SCORES WITH OR WITHOUT LOCAL
ANAESTHESIA IN NEONATAL CIRCMCISION USING PLASTIBELL
TECHNIQUE AT PLATEAU STATE SPECIALIST HOSPITAL, JOS,
NIGERIA
A DISSERTATION SUBMITTED TO THE NATIONAL POSTGRADUATE
MEDICAL COLLEGE OF NIGERIA IN PARTIAL FULFILLMENT OF THE
REQUIREMENTS FOR THE AWARD OF THE FELLOWSHIP OF
THE COLLEGE IN FAMILY MEDICINE (FMCFM)
PART II FINAL EXAMINATION
MAY 2010
BY
DR.AMINU GANGO FIKIN
DEPARTMENT OF FAMILY MEDICINE
PLATEAU STATE SPECIALIST HOSPITAL, JOS, NIGERIA
i ACKNOWLEDGEMENT
My heartfelt gratitude goes to DR STEPHEN YOHANNA for his ingenuity, thorough supervision, guidance and encouragement throughout the entire period of my training and this work. I’m also grateful to DR PITMANG, DR LAR, DR LAABES, and DR INYANG for their contribution and criticism. My gratitude goes to all the consultants of Plateau State Specialist Hospital, Jos for contributing in one way or the other during my period of training. My sincere thanks goes to DR ABUBAKAR BALLA who provided me with shelter throughout the period of my training.
ii DEDICATION
To my children, AHMED, YUSUF, HADIJA, ALHAJI GONI, BA MAINA, AWULU and ABDULMUMINI, my wife, MOGOROM FATI MAINA GORIA, and my Mother and Father. Thank you for everything you are to me.
iii CERTIFICATION
This is to certify that Dr. Aminu G. FIKIN performed the study reported in this Dissertation at Plateau
State Specialist Hospital under our supervision. We also supervised the writing of the dissertation.
SUPERVISOR
Dr. STEPHEN YOHANNA (BM, BCH; MPH; FMCGP; FWACP)
CONSULTANT FAMILY PHYSICIAN
EVANGEL HOSPITAL, JOS, NIGERIA
SIGNATURE: …………………………………………………..
DATE: ………………………………………………………….
HEAD OF DEPARTMENT
Dr. INYANG OLUBUKUNOLA (MB, BS; FMCGP)
CONSULTANT FAMILY PHYSICIAN
PLATEAU STATE SPECIALIST HOSPITAL, JOS, NIGERIA
SIGNATURE: ………………………………………….
DATE: ………………………………………………………..
iv LIST OF ABBREVIATIONS
AAP American Academy of Pediatrics
AMA American Medical Association
BC Before Christ
CRIES Crying, Requirement, Increased vital signs, facial Expression
and Sleeplessness
FLACC F ace, Legs, Activity, Cry, and Consolability
IASP International Association for Study of Pain
NFCS Neonatal Facial Coding System
NIPS Neonatal/Infant Pain Score
N-PASS Neonatal Pain Agitation and Sedation Scores
PIPP PREMATURE Infant Pain Profile
US United States
WHO World Health Organization
v TABLE OF CONTENTS
ACKNOWLEDGEMENT ...... i
DEDICATION ...... ii
CERTIFICATION ...... iii
LIST OF ABBREVIATIONS ...... iv
TABLE OF CONTENTS ...... v
LIST OF TABLES ...... viii
LIST OF FIGURES ...... ix
ABSTRACT ...... 1
CHAPTER ONE: INTRODUCTION ...... 3
1.1 INTRODUCTION ...... 3
1.2 STATEMENT OF THE PROBLEM AND PROBLEM ANALYSIS...... 6
1.3 AIM ...... 6
1.4 OBJECTIVES ...... 6
1.5 RATIONALE FOR THE STUDY...... 7
1.6 RELEVANCE OF THE STUDY TO FAMILY MEDICINE...... 7
CHAPTER TWO: LITERATURE REVIEW ...... 9
2.1 HISTORY OF CIRCUMCISION...... 9
2.2 EPIDEMIOLOGY OF CIRCUMCISION...... 14
2.3 CIRCUMCISION TECHNIQUES...... 19
2.4 NEONATAL PAIN RESPONSE DURING CIRCUMCISION...... 24
vi 2.5 PAIN ASSESSMENT TOOLS...... 32
2.6 PAIN MANAGEMENT IN NEONATES...... 37
2.7 ANAESTHESIA FOR NEONATAL CIRCUMCISION...... 44
2.8 COMPLICATIONS OF NEONATAL CIRCUMCISION...... 47
CHAPTER THREE: MATERIALS AND METHODS ...... 59
3.1 STUDY ENVIRONMENT...... 59
3.2. STUDY POPULATION...... 59
3.3 STUDY DESIGN...... 59
3.4 THE SAMPLE SIZE...... 60
3.5 SAMPLING METHOD...... 60
3.6 INCLUSION CRITERIA...... 61
3.7 EXCLUSION CRITERIA...... 61
3.8 METHOD AND INSTRUMENT OF DATA COLLECTION...... 61
3.9 METHOD OF DATA ANALYSIS...... 65
3.10 ETHICAL CONSIDERATION...... 65
CHAPTER FOUR: RESULTS...... 66
4.1 PHYSICAL CHARACTERISTICS OF THE NEONATES...... 66
4.2 SOCIO-DEMOGRAPHIC CHARACTERISTICS OF THE PARENTS...... 67
4.3 NEONATAL INFANT PAIN SCORES...... 68
4.4 COMPARISON OF MEAN NEONATAL INFANT PAIN SCORES...... 70
4.5 PHYSIOLOGICAL CHANGES DURING CIRUMCISION...... 74
4.6 DURATION OF CIRCUMCISION ...... 76
vii 4.7 COMPLICATIONS OF NEONATAL CIRCUMCISION ...... 77
4.8 REASONS FOR CIRCUMCISION...... 79
CHAPTER FIVE: DISCUSSION ...... 80
5.1 PHYSICAL CHARACTERISTICS OF NEONATES ...... 80
5.2 SOCIO-DEMOGRAPHIC CHARACTERISTICS OF THE PARENTS...... 81
5.3 NEONATAL INFANT PAIN SCORES ...... 82
5.4 PHYSIOLOGICAL AND BEHAVIOURAL CHARACTERISTICS ...... 84
5.5 COMPLICATIONS OF NEONATAL CIRCUMCISION ...... 86
5.6 DURATION OF SURGERY ...... 87
5.7 REASONS FOR NEONATAL CIRCUMCISION ...... 87
5.8 IMPLICATIONS FOR FAMILY PHYSICIANS ...... 88
5.9 CONCLUSION ...... 89
5.10 RECOMMENTATION...... 90
5.11 CONSTRAINT...... 90
REFERENCES...... 91
APPENDIX A: CONSENT FORM...... 102
APPENDIX B: QUESTIONNAIRE ...... 104
APPENDIX C: NEONATAL/INFANT PAIN SCALE (NIPS) ...... 107
APPENDIX D: ETHICAL CLEARANCE ...... 108
APPENDIX E: CIRCUMCISION INSTRUMENTS ...... 109
viii LIST OF TABLES
Table 1: Physical characteristics of Neonates 66
Table 2: Socio-demographic characteristics of parents 67
Table 3: Neonatal pain scores during surgery 68
Table 4: Mean neonatal pain scores 70
Table 5: Physiological changes during circumcision 74
ix LIST OF FIGURES
Figure 1: Comparison of Mean pain scores 73
Figure 2: Comparison Mean of duration of surgery 77
Figure 3: Complications of Neonatal circumcision 78
Figure 4: Reasons for circumcision 79
x
xi ABSTRACT
Large number of neonates with no medical indications present for circumcision at Plateau State
Specialist Hospital. There persist a wide variety of opinions among health care providers about how to treat pain in neonates. Newborns feel pain and require the same level of pain assessment and management as adult. Untreated pain in neonates may result in increased morbidity and exaggerated responses to pain in later life, and altered psychological development. It is a common place to withhold anaesthesia during neonatal circumcision because health care providers believed that neonates do not feel pain or that the pain is not significant and has no long lasting consequences.
The aim of this study was to determine whether or not anaesthesia was required for neonatal circumcision. It assessed pain scores and compared the mean pain scores and duration of surgery in neonates undergoing circumcision with or without local anesthesia.
Pain can be assessed using self-report behavioral observation, or physiological measures. Pain assessment becomes necessary when evaluating pain of circumcision. This is because pain can be prevented, reduced, managed during neonatal circumcision.
Evaluation of pain during neonatal circumcision with or without local anaesthesia was carried out in 72 neonates at Plateau State Specialist Hospital, Jos, Nigeria. They were randomly assigned to local anaesthesia and no local anaesthesia groups with computer generated random numbers and sealed in opaque unmarked envelopes containing group assignments.
1 The results showed that the mean neonatal pain scores were lower in those that received local anaesthesia and higher in those that did not receive local anaesthesia. This indicated that local anaesthesia usage during circumcision is associated with low neonatal pains scores compared to those who had no local anaesthesia.
The investigator therefore endorses the use of local anaesthesia for neonatal circumcision.
Unless another method is proven to be as effective, local anaesthesia should be used for all circumcisions.
2 CHAPTER ONE: INTRODUCTION
1.1 INTRODUCTION
Circumcision in the male is the removal of the foreskin that covers the glans of the penis. The practice of circumcision has roots in antiquity. Origins of circumcision are unknown but may have been performed as pubertal, tribal rites, religious rites or part of general societal norm.1 For example; it is a commandment in Judaism and Islam.
Circumcision has been performed in Africa for the past 5000 years with depictions found in stone age cave drawings, ancient Egyptians tombs and mummies.2 The technique for circumcision was illustrated in bass drawings on the wall of the temple of Anchama-Hor at Saqqara during the
5thBass dynasty [24000BC].2At first the procedure in Egypt was limited to members of the priesthood but was later adopted by the royalty, nobility and finally it became a universal practice. Some anthropologists believe that circumcision originated independently in different cultures, because of the fact that many of the males of the New World were circumcised when they were discovered by Columbus.2
Circumcision was introduced in Western countries as a method of treating and preventing masturbation in the 1800s.4 The procedure became more widespread between 1920 and 1950.5
In West African groups such as the Dogon and Dowayo, it is taken to represent a removal of feminine aspect of the male, turning boys into fully masculine males.6 However, in most West
African traditional societies, it has become medicalised and simply performed in infancy without ado or any particular cultural significance.7 Among the Urhobo people of Southern Nigeria it is symbolic of a boy entering into manhood.8 For Nilotic peoples such as the Kalcin and Masai, circumcision is a rite of passage to adulthood observed collectively by a number of boys every
3 few years, and boys circumcised at the same time are regarded as members of a single age set.9
When discussing elective, non-religio-ritualistic neonatal circumcision, some explain their views in terms of the perceived medical benefits of the procedure 10 (i.e. reduced incidence of urinary tract infection in infant males, decreased incidence of penile cancer in adult males, and possibly decreased susceptibility to certain sexually transmissible diseases, including human immunodeficiency virus).11 Circumcision is recommended by some physicians to treat medical conditions in males, such as phimosis, chronic inflammation of the penis, and penile cancer12 while other physicians believe there are less invasive treatments for phimosis that can be tried first.13 Such less invasive treatments include topical application of steroid cream/ointment and use of emollient creams.14
Circumcision is a surgical procedure. While the risks of circumcision-related complications are very low15 ,the complications resulting from a poorly carried out circumcision, such as post- operative bleeding, or infection can be catastrophic.16 Bleeding and infection are the most common complications of the procedure, according to the AMA, although in the majority of cases, bleeding is minor and hemostasis can be achieved by pressure application.17 Kaplan identified long term complications, including urinary fistulas, chordee, cysts, lymphoedema, ulceration of the glans, necrosis of all or part of the penis, hypospadias, epispadias, impotence and removal of too much tissue, sometimes causing secondary phimosis.18 He stated that virtually all of these complications are preventable with only a modicum of care. Unfortunately, most often such complications occur at the hands of inexperienced operators.19
Although neonatal circumcision is a painful and stressful operation, there is the belief that infants do not experience pain with the same intensity as adult.20 several techniques are employed for
4 neonatal circumcision such as Gomco clamp, Mogen clamp, Taraklamp, plastibell technique, etc.
The plastibell technique is considered less painful compared with other techniques hence its choice for this study.
Physiological changes associated with pain include: cardiovascular variables such as transcutaneous partial pressure of oxygen, and palmer sweating observed in neonates undergoing painful clinical procedures.21 In newborns undergoing circumcision or heel lancing marked increases in the heart rate and blood pressure occurred during and after the circumcision.22 The magnitude of changes in the heart rate was related to the intensity and duration of the stimulus and to individual temperaments of the babies.23 Hormonal and metabolic changes have been measured primarily in neonates undergoing circumcision, plasma cortisol levels increased markedly during circumcision.24
The behavioral changes associated with pain include: (a) Simple motor response, early studies of the motor responses of newborn infants to pinpricks reported that babies responded with a” diffuse body movement rather than a purposeful withdrawal of limbs.24 (b) Facial expression such as associated with pleasure, pain, sadness, and surprise in infants. These have been objectively validated in studies of infants being immunized 16-18. (c) Crying is the primary method of communication and also elicited by stimuli other than pain. Several studies have classified infant crying according to distress indicated and its spectrographic properties.24 Long-term painful experiences in neonate, could possibly have some psychological sequel.22 Numerous evidence suggest that even in the human fetus pain pathways as well as cortical and subcortical centers necessary for pain perception are well developed and the neurochemical system that are known to be associated with pain transmission and modulation are also intact and functional.19,23 Recent
5 data suggest that a painful experience in the newborn influence how pain is perceived later in life.
1.2 STATEMENT OF THE PROBLEM AND PROBLEM ANALYSIS.
There persists a wide variety of opinions among health care providers about how to treat pain in our neonates. Newborns feel pain and require the same level of pain assessment and management as adults. Untreated pain in neonates may result in increased morbidity and exaggerated responses to pain in later life, and altered psychosocial development. Withholding anesthesia is commonplace during neonatal circumcision because health care practitioners believed that newborns do not feel pain, or if they do, that the pain is not significant and has no long-lasting consequences. The traditional view that newborns do not feel pain was supported by the belief that pain transmission required complete nerve myelinization and a mature cerebral cortex to interpret the pain signal. However, although the newborn’s peripheral nerves are unmyelinated, complete myelinization is not a prerequisite to pain transmission.
There is need to generate data to recommend or obviate the need for local anesthesia during neonatal circumcision. This study is intended to compare pain scores of neonatal circumcision with or without local anesthesia and make recommendation for practice.
1.3 AIM
To determine whether or not anaesthesia is required for neonatal circumcision by assessing pain scores during neonatal circumcision with or without local anaesthesia
1.4 OBJECTIVES
1 To assess the pain scores in neonates undergoing circumcision with, or without local anaesthesia.
2. To compare the mean pain scores in neonates undergoing circumcision with or without local anesthesia.
6 3. To compare the mean duration of surgery in neonates undergoing circumcision with or without local anesthesia.
4. To make appropriate recommendations on the use of local anesthesia during neonatal circumcision.
1.5 RATIONALE FOR THE STUDY.
A large number of neonates with no medical indications present for circumcision at Plateau
State Specialist Hospital.
Acute pain is one of the most common adverse stimuli experienced by infants as a result of injury, illness or during medical procedures.19 It is associated with increased anxiety, avoidance, somatic symptoms and increased parental distress.20
Pain can be assessed using self-report, behavioral observation, or physiological measures.24
Pain assessment becomes necessary when evaluating the practice of circumcision. This is because pain can be prevented, reduced, and managed during neonatal circumcision to alleviate neonatal and parental anxiety, somatic symptoms and distress associated with the procedure. It will improve the quality of care for male newborns undergoing circumcision.
1.6 RELEVANCE OF THE STUDY TO FAMILY MEDICINE.
Family medicine as a discipline identifies with the following principles. The family physician is committed to the person and seeks to understand the context of the illness; every contact is seen as an opportunity for disease prevention and for health education; importance is attached to the subjective aspects of medicine.
Anaesthesia is generally not administered for neonatal circumcision for a variety of reasons; among them are the consideration that the procedure is of relatively short duration of intervention and the perceived lack of importance of the pain. It is now recognized that neonates are capable of both perceiving and exhibiting reproducible response to pain and that pain in neonates may have long-term effects, for instance, on pain memories.
7
Evaluation of pain scores will provide information to the practicing family physicians and create awareness about rating, and treatment of pain during neonatal circumcision. This study is of particular relevance in helping to modify attitudes of Family physicians towards neonatal circumcision.
8 CHAPTER TWO: LITERATURE REVIEW
2.1 HISTORY OF CIRCUMCISION.
It has been variously suggested that circumcision began as a religious sacrifice and a rite of passage marking a boy's entrance into adulthood.25 It is believed that it began as a form of sympathetic magic to ensure virility, and a means of suppressing or enhancing sexual pleasure, and an aid to hygiene where regular bathing was impractical. It is also believed that it is a means of marking those of lower or higher social status, and a means of differentiating a circumcising group from their non-circumcising neighbors.
Others believed that it is a means of discouraging masturbation or other socially proscribed sexual behaviors, to remove excess pleasure, to increase a man's attractiveness to women, and a demonstration of one's ability to endure pain, or a male counterpart to menstruation or the breaking of the hymen. It is possible that circumcision arose independently in different cultures for different reasons.26
The oldest documentary evidence for circumcision comes from ancient Egypt. Tomb artwork from the Sixth Dynasty, 2345-2181 BC, showed men with circumcised penises, and one relic from this period showed the rite being performed on a standing adult male.27 The Egyptian hieroglyph for penis depicts either a circumcised or an erect organ. The examination of Egyptian mummies has found some with foreskins and others who were circumcised.
Circumcision was common, although not universal, among ancient Semitic peoples. The Book of
Jeremiah, written in the sixth century BC, lists the Egyptians, Jews, Edomites, Ammonites, and
Moabites as circumcising cultures.26, 27 Herodotus, writing in the fifth century BC, added the
9 Colchians, Ethiopians, Phoenicians, and Syrians to that list.27 In the aftermath of the conquests of Alexander the Great, Greek dislike of circumcision led to a decline in its incidence among many people’s that had previously practiced it. The writer of the 1 Maccabees wrote that under the Seleucids, many Jewish men attempted to reverse their circumcision so they could exercise in Greek gymnasia, where nudity was the norm.26, 27 First Maccabees also relates that the
Seleucids forbade the practice of brit milah, Jewish circumcision, and punished those who performed it as well as the infants who underwent it with death.28
In West Africa infant circumcision may have had some tribal significance as a rite of passage or otherwise in the past. Circumcision is commonly practiced in the Polynesian islands of Samoa,
Tonga, Niu, and Tikopia.29 In Samoa it is accompanied by celebration. Among West African animist groups such as the Dogon and Dowayo, it is taken to represent a removal of feminine aspect of the male, turning boys into fully masculine males.30 Although in many West African traditional societies circumcision has become medicalized and simply performed in infancy without ado or any particular conscious cultural significance among the Urhobo people of
Southern Nigeria, it is symbolic of a boy entering manhood. Today in some non-Muslim Nigerian societies it is medicalized and is simply a cultural norm.31 For Nilotic peoples such as the Kalcniin and the Maasai, circumcision is a collective rite of passage observed collectively by a number of boys every few years and boys circumcised at the same time are taken to be members of a single age set.,30
Circumcision is part of initiation rites in some African, Pacific Islanders, and Australian aboriginal traditions in remote areas such as Arnhem Land where the practice was introduced by Makassan traders from Sulawesi in the Indonesian Archipelago.31, 32
10 In some South African ethnic groups, circumcision has roots in several belief systems, and is performed most of the time on teenage boys: The young men in the Eastern Cape belong to the
Xhosa ethnic group for whom circumcision is considered part of the passage into manhood.33
Male circumcision in East Africa is a rite of passage from childhood to adulthood, but is only practiced in some tribes. Some peoples in East Africa do not practice male circumcision for example the Luo of western Kenya. Amongst the Kikuyu people of Kenya and the Maasai people of Kenya and Tanzania, male circumcision has historically been the graduation element of an educational program which taught tribal beliefs, practices, culture, religion and history to youth who were on the verge of becoming fully fledged members of society.24
The circumcision ceremony was very public, and required a display of courage under the knife in order to maintain the honor and prestige of the young man and his family. The only form of anesthesia was a bath in the cold morning waters of a river, which tended to numb the senses to a minor degree. The youths being circumcised were required to maintain a stoic expression and not to flinch from the pain.
In the modern context in East Africa, the physical element of male circumcision remains (in the societies that have historically practiced it) but without most of the other accompanying rites, context and programs. For many, the operation is now performed in private on one individual, in a hospital or doctor's office. Anesthesia is often used in such settings. There are tribes however, that do not accept this modernized practice. They insist on circumcision in a group ceremony, and a test of courage at the banks of a river. This traditional approach is common amongst the
Meru and the Kisii tribes of Kenya.28, 29 After circumcision, young men became members of the
11 warrior class, and were free to date and marry. The graduates became a fraternity which served together, and continued to have mutual obligation to each other for life.
Historically, routine neonatal circumcision was promoted during late Victorian times in the
English-speaking parts of Canada, Australia, New Zealand, the United States and the United
Kingdom and was widely practiced during the first part of the 20th century in these countries.
However, the practice declined sharply in the United Kingdom after the Second World War, and somewhat later in Canada, Australia and New Zealand. It has been argued that the practice did not spread to other European countries because others considered the arguments for it being fallacious.
In South Korea, circumcision was largely unknown before the establishment of the United States trusteeship in 1945. More than 90% of South Korean high school boys are now circumcised, but the average age of circumcision is 12 years, which makes South Korea a unique case.33 Routine infant circumcision has been abandoned in New Zealand and Britain, and is now much less common in Australia and in Canada. The decline in circumcision in the United Kingdom followed the decision by the National Health Service (NHS) in 1948 not to cover the procedure following an influential article by Douglas Gardiner which claimed that circumcision resulted in the deaths of about 16 children under 5 each year in the United Kingdom.24, 25, 26, 27
Several hypotheses had been raised in explaining the American public's acceptance of infant circumcision as preventive medicine. The success of the germ theory of disease had not only enabled physicians to combat many of the postoperative complications of surgery, but had made the wider public deeply suspicious of dirt and bodily secretions. Accordingly, the smegma that collects under the foreskin was viewed as unhealthy, and circumcision readily accepted as good
12 penile hygiene. Second, moral sentiment of the day regarded masturbation as not only sinful, but also physically and mentally unhealthy, stimulating the foreskin to produce the host of maladies of which it was suspected. In this climate, circumcision could be employed as a means of discouraging masturbation. All about the Baby, a popular parenting book of the 1890s, recommended infant circumcision for precisely this purpose.32,33 Interestingly, a 1410-man survey in the United States in 1992, Laumann found that circumcised men were more likely to report masturbating at least once a month.25,27
With the proliferation of hospitals in urban areas, childbirth, at least among the upper and middle classes, was increasingly undertaken in the care of a physician in a hospital rather than that of a midwife in the home. It has been suggested that once a critical mass of infants were being circumcised in the hospital, circumcision became a class marker of those wealthy enough to afford a hospital birth.26, 27
By the 1920s, advances in the understanding of disease had undermined much of the original medical basis for preventive circumcision. Doctors continued to promote it, however, as good penile hygiene and as a preventive measure for a handful of conditions local to the penis: balanitis, phimosis, and penile cancer. Prior to 1989, the American Academy of Pediatrics had a long-standing opinion that medical indications for routine circumcision were lacking. This stance, according to the AMA, was reversed in 1989, following new evidence of reduction in risk of urinary tract infection.27
A study in 1987 found that the prominent reasons for parents choosing circumcision were concerns about the attitudes of peers and their sons' self concept in the future, rather than medical concerns.38 A study reported that reasons for circumcision included ease of hygiene,
13 ease of infant circumcision compared with adult circumcision, 63 percent for medical benefit, and father having been circumcised. The authors commented that Medical benefits were cited more frequently in this study than in past studies, although medical issues remain secondary to hygiene and convenience. A study reported that, the most important reason to circumcise or not circumcise the child was health reasons.27 Other studies speculated that increased recognition of the potential benefits may be responsible for an observed increase in the rate of neonatal circumcision in the USA between 1988 and 2000. In a 2001 survey, 86.6% of parents felt respected by their medical provider, while 13.4% felt less respected by their medical provider.28
The major medical societies in Britain, Canada, Australia and New Zealand do not support routine non-therapeutic infant circumcision. Major medical organizations in the United States do not recommend routine circumcision, but instead state that parents should decide what is in their child's best interests. Neonatal circumcision remains the most common pediatric operation carried out today.29
2.2 EPIDEMIOLOGY OF CIRCUMCISION.
The World Health Organization states that as of 2006, about 30% of males or approximately 665 million men are circumcised worldwide.37 Other estimates of the proportion of males that are circumcised worldwide include one sixth, one third, and between 30 and 40%.35
Data from a national survey conducted from 1999 to 2002 found that the overall prevalence of circumcision in the United States was 79% to 91% of men born in the 1970s, and 83% of boys born in the 1980s were circumcised.42 An earlier survey, conducted in 1992, found a prevalence of 77% in US-born boys, and 42% in non-US born boys.33 A recent study in USA, which used data from the Nationwide Inpatient Sample, a sample of 5-7 million of the nation's total inpatient stays, and representing a 20% sample taken from 8 states in 1988 and 28 in 2000, showed that
14 neonatal circumcisions rose from 48.3% in 1988 to 61.1% in 1997.Figures from another
Nationwide Hospital Discharge Survey stated that circumcision rates declined from 64.7% in
1980 to 59.0% in 1990, rose to 64.1% in 1995, and fell again to 55.9% in 2003. It is shown that the western region of the United States had seen the most significant change, declining from
61.8% in 1980 to 31.4% in 2003.The decline in the western region had been partly attributed to increasing births among Latin Americans, who usually do not circumcise.34
According to the World Health Organization, 80% or more of males in South Korea are circumcised.37 A study of 20-year old South Korean men found that 78% were circumcised.37
The authors commented that South Korea has possibly the largest absolute number of teenage or adult circumcisions anywhere in the world. Circumcision started through contact with the
American military during the Korean War. South Korea has an unusual history of circumcision.35
Statistics from these national samples differ from higher rates that have been documented in individual centers. One explanation is that, the published results of national statistical surveys represent only coded diagnoses obtained from birth centers; the reported figures do not include males who are circumcised at a later date for religious, medical, or personal reasons or who received newborn circumcision that was not coded.35, 36
According to the American Academy of Pediatrics, approximately 48% of Canadians are circumcised.24 A policy statement indicates that Canadian neonatal circumcision rates are 10 to
30%.24,25 A national survey in 2003 found that 15.8% of men in the United Kingdom ,ages 16-44 were circumcised.37,38 Eleven point seven percent of 16-19 year olds and 19.6% of 40-44 year olds said they had been circumcised.38 A study by Dunsumur et al reported that the proportion of
English boys circumcised for medical reasons had fallen from 35% in the early 1930s to 6.5% by
15 the mid-1980s.3 An estimated 3.8% of male children in the UK in 2000 were being circumcised by the age of 15.3
In Finland, data from 1996-1998 indicate that about 7.1% of males are circumcised. 38 The overall prevalence of circumcision in Spain is reported to be 1.8%. In 1986, only 511 out of approximately 478,000 Danish boys aged 0-14 years were circumcised.38 This corresponds to a cumulative national circumcision rate of around 1.6% by the age of 15 years.38 A survey by
Richter et al of Australian men, conducted in 2001-2002, reported that 58.7% were circumcised.
In another study by Richter, the infant circumcision rate in Australia was 12.9% as of 2003.
However, rates in the states varied, with highest rates in Queensland 19.3%, New South Wales
16.3% and South Australia 14.3%, and the lowest in Tasmania 1.6%.41
According to the World Health Organization, fewer than 20% of males are circumcised in New
Zealand. In a study of men born in 1972-1973 in Dunedin, 40.2% were circumcised. In a study of men born in 1977 in Christchurch, 26.1% were circumcised. Another survey conducted by Kozak et al in Waikato found that 7% of male infants were circumcised.39
Studies indicate that about 62% of African males are circumcised overall.29 However, these rates differ by region, ethnic and religious groups.30 A study by Agberia comment that most of the currently available data on the prevalence of male circumcision are several decades old, while several of the recent studies were carried out as adjuncts to demographic and health surveys and were not designed to determine the prevalence of male circumcision.30
16 The following list below states the proportion of males circumcised in Africa by country.
Epidemiology of circumcision in Africa.
Country Rate (%) (Williams et al)36 Rate (%) (WHO)37
Angola 66 >80
Central African Republic 67 20-80
Chad 64 >80
Republic of the Congo 70 >80
Democratic Republic of the Congo 70 >80
Gabon 93 >80
Burundi 2 <20
Djibouti 94 >80
Eritrea 95 >80
Ethiopia 76 >80
Kenya 84 >80
Rwanda 10 <20
Somalia 93 >80
Sudan 47 20-80
Tanzania 70 20-80
Uganda 25 20-80
17 Botswana 25 <20
Lesotho 0 20-80
Malawi 17 <20
Mozambique 56 20-80
Namibia 15 <20
South Africa 35 20-80
Swaziland 50 <20
Zambia 12 <20
Zimbabwe 10 <20
Benin 84 >80
Burkina Faso 89 >80
Cameroon 93 >80
Equatorial Guinea 86 >80
Gambia 90 >80
Ghana 95 >80
Guinea 83 >80
Guinea-Bissau 91 >80
Côte d'Ivoire (Ivory Coast) 93 20-80
Liberia 70 >80
18 Mali 95 >80
Mauritania 78 >80
Niger 92 >80
Nigeria 81 >80
Senegal 89 >80
Sierra Leone 90 >80
Togo 93 >80
In Nigeria, hospital based records showed about 79.5% of neonate are been circumcised.5,6,7,8 In
Jos, North central zone a study by Dakum et al found that 1.1% of urologic day-care surgery
performed in 2005 was circumcision.8
2.3 CIRCUMCISION TECHNIQUES
Circumcision removes the foreskin from the penis. For infant circumcision, clamps, such as the
Gomco clamp, Plastibell, Mogen etc are often used.40 These clamps are meant to protect the
glans while they apply pressure to the foreskin and stop any bleeding.
2.3.1 PLASTIBELL CLAMP
A plastic bell with a groove at the back of it is slipped between the glans and the foreskin; an
initial dorsal slit may be needed to allow the bell to be placed. The foreskin is pulled slightly
forward and suture material is looped around in the groove and a surgical knot tied tightly. The
thread cuts off the blood supply to the foreskin which withers and drops off, taking the Plastibell
with it, in 7 to 10 days. It is usual, but not essential, to remove the excess foreskin after the knot
is tied - this is mainly cosmetic so that the boy already looks circumcised when returned to his
19 parents. It also reduces the volume of dead foreskin which will drop off and thus reduces parental anxiety a bit.
The glans and frenulum are protected by the bell. The frenulum will never be cut when using the
Plastibell. Tightness is moderate to slack. Because the bell remains on the penis for a week or so, the foreskin must not be pulled so tightly over the bell to prevent digging into the glans or obstruct the urethra. The groove is always forward of the corona of the glans and hence some inner foreskin must necessarily be retained. Only small sizes of Plastibell are generally marketed and hence the method is only suitable for pre-pubescent boys, the makers say up to about 12 years of age only. No particular surgical skill is required beyond being able to tie a surgical knot.
The Plastibell is thus very suitable for use by midwives and medical auxiliaries where doctors are not available. With the Plastibell clamp, the foreskin and the clamp fall off in three to seven days.
2.3.2 GOMCO CLAMP
Before a Gomco clamp is used, a section of skin is crushed with a hemostat then slit with scissors. Then, the foreskin is drawn over the bell shaped portion of the clamp, which is then inserted through a hole in the base of the clamp, and the clamp is tightened, crushing the foreskin between the bell and the base plate, this crushing action provides the homeostasis necessary to limit bleeding. With the flared bottom of the bell fit tightly against the hole of the base plate, the foreskin is cut away with a scalpel from above the base plate, while the bell covers the glans to prevent it being reached by the scalpel.
2.3.3 MOGEN CLAMP.
With a Mogen clamp, used by many physicians and all mohels, Jewish ritual circumcisers, the foreskin is dissected away from the glans with a blunt probe and/or curved hemostat as with the first part of the Gomco procedure. The foreskin is then grabbed dorsally with a straight hemostat,
20 and tented up as the Mogen clamp is slid between the glans and hemostat. The clamp is then locked shut and a scalpel used to remove the foreskin from the flat upper side of clamp.41
2.3.4 SHIELD AND KNIFE METHOD.
This is the method traditionally used for a Jewish circumcision. The foreskin is pulled out in front of the glans, and a metal shield with a slot in it is slid over the foreskin immediately in front of the glans. The scalpel is run across the face of the shield to remove the foreskin. The glans is protected by the shield and the frenulum is not touched. The inner foreskin is then slit back to behind the glans and cut off. In a non-ritual circumcision by this method the inner foreskin may be similarly removed, or may be left intact and just folded back. No stitches are used; the wound simply being bandaged up. The tightness of the finished result depends on the operator's skill and whether or not the inner skin is also removed. Since the cut is always in front of the glans a relatively loose result is normal, particularly when the inner skin is not removed - the minimum amount of inner foreskin left being equal to the length of the glans. This method is normally only used on infants. For older children or adults the Forceps Guided method would be used.41
2.3.5 FORCEPS GUIDED METHOD.
This is similar to the Shield and Knife method for older children and adults. The foreskin is pulled out in front of the glans and a pair of stout locking forceps is clamped across it, parallel to the corona of the glans and immediately in front of the glans. The scalpel is run across the face of the forceps furthest from the glans to remove the foreskin. The glans is protected by the forceps.
This method does not cut the frenulum but it can be removed before or after the circumcision if desired. The tightness and relative amounts of inner and outer foreskin remaining depend on adjustments made before the forceps are fully closed. The minimum amount of inner skin remaining equals the length of the glans. The cut edges of inner and outer skin are then normally brought together and held by stitches.42
21 2.3.6 FREEHAND METHOD.
The foreskin is slid back along the shaft and a freehand cut is made around the shaft as far back as the scar line is to be placed. The foreskin is returned to cover the glans and another cut is made around the shaft at the same position along its length as the first. A longitudinal cut is made between the two circumferential ones and the strip of skin removed. The edges are pulled together and sutured. The glans and frenulum are not protected. The frenulum can be included in the main cutting or can be cut separately if desired. Results depend very much on the skill of the surgeon, but can be as tight or loose as desired with the scar line anywhere that is wanted.43, 44
2.3.7 TARA KLAMP METHOD.
This is a Malaysian invention which works in a very similar fashion to the Plastibell except that instead of having to tie suture material around a groove in the bell, plastic arms lock into place to force two surfaces into tight contact; with the foreskin trapped between them. The device is much more bulkier than a Plastibell and remains on the penis for 7 to 10 days until it is removed or falls off with the dead foreskin. No foreskin is cut unless a dorsal slit is required to gain access for the bell part. The glans and frenulum are protected and the frenulum is never cut. The result is moderate to slack as with the Plastibell.45
2.3.8 SMART KLAMP METHOD.
This works in the same general way as the Tara KLamp by trapping the foreskin between an outer ring and an inner tube, and thus cutting off the blood supply to the foreskin. Whereas the
Tara KLamp is an all-in-one design, with the locking arms at the top, the SmartKlamp consists of separate inner tube and outer clamping/locking part with the locking arms at the side. Once the clamp is in place the excess foreskin is removed using the inside of base plate as a guide. The glans and frenulum are protected. The result is normally moderate to slack.46
22 2.3.9 ZHENXI RINGS METHOD.
A grooved sleeve is passed over the glans to sit just behind the corona. The foreskin is replaced over this sleeve. A hinged plastic clamping ring is fitted over the sleeve, the position of the foreskin is adjusted and the nut tightened to hold the foreskin in place. An elastic cord is then wound tightly around the penis, compressing the foreskin into the groove of the sleeve below it.
This cuts off the blood supply and the foreskin forward of it dies and falls off. The glans and frenulum are protected so the frenulum remains intact. The result is expected to be moderately tight, depending on the adjustment before clamping.47
2.3.10: BONE FORCEPS METHOD.
Bone forceps have double action joints that allow a surgeon to cut with ease and precision. The foreskin is pulled out in front of the glans and a pair of stout locking forceps is clamped across it, parallel to the corona of the glans and immediately in front of the glans. The bone forceps is applied furthest from the glans and tightened, crushing the foreskin; this crushing action provides the homeostasis necessary to limit bleeding and this remove the foreskin.
2.3.11: LASER METHOD.
There have been reports of the use of laser surgery for circumcision. Laser circumcision was first reported as having been used in Israel to circumcise hemophiliac boys who could not otherwise have been circumcised. The glans and frenulum are not protected. Tightness and scar placement are both unknown quantities.48
There are a variety of other patented clamps and shields, all of which are related in some way to the traditional Shield and Knife method or the Gomco Clamp method. There are also numerous methods of freehand working which are variations on either the Forceps Guided or the Sleeve
Resection method.
23 2.4 NEONATAL PAIN RESPONSE DURING CIRCUMCISION.
Pain, a sensory experience, begins with the transmission of an impulse by the sensory receptors in the skin and other body tissues. Pain impulses are transmitted from the sensory receptors in the skin or other organs via C- and A-delta fibers in the peripheral nerves to the dorsal horn in the spinal cord, then to the brain stem, the thalamus, and finally to the cerebral cortex.
Ultimately, a process known as descending modulation assists to dampen specific pain impulses, presumably as a protective mechanism to modulate or moderate severe pain.49
When pain impulses are relayed to the spinal cord, the ascending neurons originating in the dorsal horn of the spinal cord send the pain impulse to different areas of the cerebral cortex. A study responsible for the Gate Control Theory of pain, described two distinct ascending pathways for pain: the lateral and medial pathways. The lateral pathway is responsible for transmitting phasic pain impulses to the cerebral cortex.49 Phasic pain is that which is first felt after an injury and is brief, with an intensity that rapidly rises and then falls, similar to pain felt during the initial lance for a heel stick procedure. The medial ascending pathway is responsible for transmitting tonic pain. Tonic pain usually follows phasic pain and is prolonged and persistent, often described by adults as diffuse in nature.49 Unlike the lateral pathway, the medial pathway conducts the sensory information to the limbic area of the cerebral cortex that provides the psychological response to pain and makes the pain experience unique for each person. Pain impulses are transmitted through unmyelinated C-fibers and thinly myelinated A-delta-fibers in the adult.50
24 2.4.1 ANATOMICAL AND FUNCTIONAL REQUIREMENT FOR PAIN PERCEPTION IN
NEONATES.
Neural pathways for pain may be traced from sensory receptors in the skin to sensory areas in the cerebral cortex of newborn. The density of nociceptive nerve endings in the skin of the newborn is similar to or greater than that in adult skin.
Quantitative neuroanatomical data have shown that nociceptive nerve tracts in the spinal cord and brain stem and thalamus are completely myelinated by thirty weeks of intrauterine life.
Whereas the thalamocortical pain fibres in the posterior limb of the internal capsule and corona radiata are myelinated by thirty-seventh week.
Development of the fetal neocortex is present at eighth week of gestation, and by twentieth week each cortex has a full complement of 109 neurons. The dendritic processes of the cortical neurons undergo profuse arborizations and develop synaptic targets for the incoming thalamocortical fibres and intracortical connections. The timing of the thalamocortical connection is of crucial importance for cortical perception. Since most pathways to the neocortex have synapses in the thalamus.49, 50
Several lines of evidence suggest that the complete nervous system is active during prenatal development and that detrimental and developmental changes in any part would affect the entire system. Human newborns do have the anatomical and functional components required for the perception of painful stimuli. These stimuli may undergo selective transmission, Inhibition, or modulation by various neurochemical mechanism associated with pain pathways in the fetus and newborn.50
25 Researchers studying fetal and newborn neuroanatomy and physiology confirmed that newborns, both term and preterm, have the peripheral structures needed to transmit pain that are similar to those of adults but with the following important differences: Pain impulses are predominantly transmitted through the nonmyelinated C-fibers. Signal transmission is less specific within the spinal cord. Sensory nerve cells in the spinal tract are more excitable leading to a greater and more prolonged reflex response. Descending modulation is immature and ineffective. These differences may result in newborns perceiving pain in a more intense fashion than adults.49, 50
A study demonstrated that premature infants have a lower pain threshold than term infants, indicating a more intense transmission of painful stimuli via the spinal cord, which can be further intensified with repeated painful stimulation.51 The heal prick procedure can be used as an example of the reaction and response to pain: An infant senses the lance and immediately withdraws the foot. In the preterm infant this withdraw reflex may be less dramatic because of less muscle strength compared with the term newborn. Following the withdrawal reflex, the infant cries and responds with the classic cry face, squeezed eyes, marked nasolabial folds, and gaping mouth. This response, commonly witnessed by health care providers during circumcision and venipuncture are examples of an intact sensory pathway that transmits painful stimuli.51
2.4.2: NEUROCHEMICAL SYSTEMS ASSOCIATED WITH PAIN PERCEPTION.
Diverse alleged neurotransmitters called the tachykinins (substanceP,neurokinin A, neuromedin
K ) have been well known in the central nervous system, but only substance P has been investigated thoroughly and shown to have a role in the transmission and control of pain impulses.48-51 Neural elements containing substance P and its receptors appear in the dorsal- root ganglia and dorsal horns of the spinal cord at twelve to sixteen weeks of gestation.51 A high density of substance P fibers and cells have been observed in multiple areas of the fetal brain
26 stem associated with pathways for pain perception and control and visceral reactions to pain.52
Substance P fibers and cells have also been found in the hypothalamus, mamillary bodies, thalamus, and cerebral cortex of human fetuses early in the development.52 Many studies have found higher densities of substance P and its receptors in neonates than in adults of the same species.49-52
2.4.3. ENDOCRINE RESPONSE TO PAIN IN NEONATES.
Hormonal and metabolic changes have been measured primarily in neonates undergoing surgery, although there are limited data on the neonatal responses to venipuncture and other minor procedures. Plasma renin activity increased significantly five minutes after venipuncture in full-term neonates and returned to basal levels sixty minutes thereafter; no changes occurred in the plasma levels of cortisol, epinephrine, or norepinephrine after venepuncture.52 In preterm neonates receiving ventilation therapy, chest physiotherapy and endotracheal suctioning produced significant increases in plasma epinephrine and norepinephrine; this response was decreased in sedated infants.51,51 In neonates undergoing circumcision without anesthesia, plasma cortisol levels increased markedly during and after the procedure.49 Similar changes in cortisol levels were not inhibited in a small number of neonates given a local anaesthetic,49 but the efficacy of the nerve block was questionable in these cases.
Further detailed hormonal studies in preterm and full-term neonates who underwent surgery under minimal anaesthesia documented a marked release of catecho-lamines, growth hormone, glucagon, cortisol, aldosterone, and other corticosteroids, as well as suppression of insulin secretion.50 These responses resulted in the breakdown of carbohydrate and fat stores, leading to severe and prolonged hyperglycemia and marked increases in blood lactate, pyruvate, total ketone bodies, and nonesterified fatty acids.49,50 Increased protein breakdown was documented during and after surgery by changes in plasma amino acids, elevated nitrogen excretion, and increased 3-methyl- histidine: creatinine ratios in the urine. Marked differences also occurred
27 between the stress responses of premature and full-term neonates and between the responses of neonates undergoing different degrees of surgical stress.52 Possibly because of the lack of deep anaesthesia, neonatal stress responses were found to be three to five times greater than those in adults, although the duration was shorter.51 These stress responses could be inhibited by potent anaesthetics, as demonstrated by randomized, controlled trials of halothane and
Fentanyl. These trials showed that endocrine and metabolic stress responses were decreased by halothane anaesthesia in full-term neonates.51
The stress responses of neonates undergoing cardiac surgery were also decreased in randomized trials of high-dose fentanyl and sufentanil anesthesia.52 These results indicated that the nociceptive stimuli during surgery performed with minimal anaesthesia were responsible for the massive stress responses of neonates.
Neonates who were given potent anaesthetics in these randomized trials were more clinically stable during surgery and had fewer postoperative complications as compared with neonates under minimal anaesthesia.51, 52 There is preliminary evidence that the pathologic stress responses of neonates under light anaesthesia during major cardiac surgery may be associated with an increased postoperative morbidity and mortality. Changes in plasma stress hormones
(e.g., cortisol) can also be correlated with the behavioural states of newborn infants, which are important in the postulation of overt subjective distress in neonates responding to pain.51, 52
The endocrine responses to pain originate in the cerebral cortex. The intact cerebral cortex of a newborn is functionally mature and able to mount an adequate response to pain and stress.
Through a complex array of interactions, the cerebral cortex orchestrates the release of catecholamines, inflammatory markers, and other important enzymes that mobilize the body to respond to painful stimuli. A study by Schoen et al, it was found that the preterm infant’s ability
28 to mount an endocrine and hormonal response to pain can be modulated with sufficient anaesthesia during surgery.52
2.4.4 PHYSIOLOGIC CHANCES ASSOCIATED WITH PAIN.
Circumcision is a surgical procedure that involves separating the foreskin from the glans and then cutting it off. It is typically accomplished with a special clamp device. Several studies confirm that circumcision is extremely painful.53 It has been described as the most painful amongst the procedures performed in neonatal medicine because of the rich innervations of the perineal region. In one study, researchers concluded that the pain was severe and persistent.53
Changes in cardiovascular variables, transcutaneous partial pressure of oxygen, and palmar sweating have been observed in neonates undergoing painful clinical procedures. In preterm and full-term neonates undergoing circumcision or heel lancing, marked increases in the heart rate and blood pressure occurred during and after the procedure. The magnitude of changes in the heart rate was related to the intensity and duration of the stimulus and to the individual temperaments of the babies.51, 50
Increases in heart rate of fifty-five beats per minute have been recorded, about a fifty percent increase over the baseline. After circumcision, the level of blood cortisol increased by a factor of three to four times the level prior to circumcision. Investigators reported, there is no doubt that circumcisions are painful for the baby. Indeed, circumcision has become a model for the analysis of pain and stress responses in the newborn.53 They report that the infant will cry vigorously, tremble, and in some cases become mildly cyanotic because of prolonged crying.
29
2.4.5 BEHAVIOURAL CHANGES ASSOCIATED WITH PAIN.
According to adult listeners in one study, the infant’s response during circumcision included a cry that changed with the level of pain being experienced. The most invasive part of the procedure caused the longest crying.53 Changes in the patterns of neonatal cries have been correlated with the intensity of pain experienced during circumcision and were accurately differentiated by adult listeners.52 In other studies of the painful procedures, neonates were found to be more sensitive to pain than older infants ,those two to twelve months old, but had similar latency periods between exposure to a painful stimulus and crying or another motor response.49,50,51
This supports the contention that slower conduction speed in the nerves of neonates is offset by the smaller inter-neuron distances traveled by the impulse. These cries were high pitched and were judged most urgent. A subsequent study confirmed that cries with higher pitch were perceived to be more distressing and urgent. Excessive crying can itself cause harm. Using a pacifier during circumcision reduced crying but did not affect hormonal pain response.52
Therefore, while crying may be absent; other body signals demonstrate that pain is always present during circumcision.
Beginning in the 1970s, a few studies investigated the effect of circumcision on infant behaviour.
Alterations in complex behavioural and sleep-wake cycles have been studied mainly in newborn infants undergoing circumcision without anesthesia. Emde and coworkers observed that painful procedures were followed by prolonged periods of non-rapid-eye-movement sleep in newborns and confirmed these observations in a controlled study of neonates undergoing circumcision without anaesthesia.51 Similar observations have been made in adults with prolonged stress.
Other subsequent studies have found increased wakefulness and irritability for an hour after
30 circumcision, an altered arousal level in circumcised male infants as compared with female and uncircumcised male infants, and an altered sleep-wake state in neonates undergoing heel-stick procedures.49 In a double-blind, randomized controlled study using the Brazelton Neonatal
Behavioral Assessment Scale, ninety percent of neonates had changed behavioral states for more than twenty-two hours after circumcision, whereas only sixteen percent of the uncircumcised infants did.51 It was therefore proposed that such painful procedures may have prolonged effects on the neurologic and psychosocial development of neonates.
Some studies found differences in sleep patterns and more irritability among circumcised infants.
In addition, changes in infant-maternal interaction were observed during the first twenty-four hours after circumcision. For example, breast- and bottle-fed infants’ feeding behavior has been shown to deteriorate after circumcision. Other behavior differences have been noted on the day following the procedure.54
The American Academy of Pediatrics (AAP) Task Force on Circumcision noted these various behavioral changes resulting from circumcision in their report. Researchers found that European reports of newborn infant responses to hearing and taste stimulation showed little difference in responses between males and females, while related tests on American infants showed significant gender differences. Investigators suggested that these differences could be the result of circumcision and not gender. 54
In one of the most important studies by Joyce et al, the behaviour of nearly 90 percent of circumcised infants significantly changed after the circumcision. Some became more active, and some became less active. The quality of the change generally was associated with whether they were crying or quiet respectively at the start of the circumcision. This suggests the use of
31 different coping styles by infants when they are subjected to extreme pain. In addition, the researchers observed that circumcised infants had lessened ability to comfort themselves or to be comforted by others.55 Untreated newborn pain can contribute significantly to neonatal morbidity and mortality. High postoperative mortality, poor growth related to prolonged protein catabolism, and increased time on mechanical ventilation have been attributed to untreated or poorly treated pain. Additionally, there may be long-term consequences for the fragile infant exposed to multiple painful procedures during a critical time in brain development. The
International Evidence-Based Group for Neonatal Pain, describe a propensity toward anxiety disorders and an exaggerated response to pain in rat pups exposed repeatedly to painful procedures.
In general, untreated or undertreated pain in the newborn includes the following physiologic and biochemical sequalae: hyperglycemia, increased protein catabolism, increased oxygen consumption, decreased gut motility, increased heart rate and blood pressure, and decreased transcutaneous oxygenation.
2.4.6 MEMORY OF PAIN IN NEONATES.
The perseverance of specific behavioral changes after circumcision in neonates implies the presence of memory. In the short term, these behavioral changes may disrupt the adaptation of newborn infants to their postnatal environment, the development of parent-infant bonding, and feeding schedules. 55
2.5 PAIN ASSESSMENT TOOLS.
Neonatal pain evaluation can be complex and challenging, but is vital to ensure appropriate pain management. The Joint Commission on the Accreditation of Healthcare Organizations and other
32 regulatory agencies require pain assessment at regular intervals throughout the hospital stay. In
fact, some health care facilities now identify pain assessment as the fifth vital sign.56
To successfully assess pain, family physicians must have the critical thinking skills necessary to distinguish pain behaviours from other behaviors that occur apart from painful situations. Pain behaviours have been observed in the newborn for more than 20 years. The cry face, including brow bulge, gaping mouth and nasolabial folds, appears to be the most specific indicator of pain across all gestational ages, and is frequently included as a primary element in pain assessment tools. Term and near-term infants frequently exhibit pain by crying and increased body movement accompanied by tachycardia and elevated blood pressure. In contrast, preterm infants, particularly the most immature, may become lethargic and unresponsive. This trend has been explained not as a lack of pain, but as a failure of the central nervous system to mount a response to pain.57
The International Association for the Study of Pain (IASP), recognizing the inability of the nonverbal and preverbal patient to clearly communicate their pain experience, revised their classic definition of pain to include this phenomenon: The inability to communicate in no way negates the possibility that an individual is experiencing pain, and is in need of appropriate pain- relieving treatment. Clearly, those who provide health care to newborns should recognize that a lack of pain response does not necessarily indicate absence of pain. Moreover, effective pain assessment requires the use of the most reliable and valid multidimensional instruments.58
Evaluation of newborn pain is not easy and complex for many reasons. Although many assessment tools are available for clinical use, few serve all populations or are applicable in all situations. Most tools do not distinguish pain from generalized distress nor measure the
33 presence of chronic pain. Compounding this difficulty is that the responses vary from infants of differing gestational ages. For instance, a preterm infant has a much less robust and variable response to pain compared with the term infant. To address problems related to the complexities of pain assessment, family physicians should use pain assessment tools that are multidimensional scoring behavioral as well as physiological parameters, reliable and valid, as well as clinically useful and appropriate for gestational age.59
Validity, reliability and clinical utility are all important considerations when choosing a pain assessment tool. Validity refers to the ability of the pain tool to measure pain as an isolated condition differentiated from other conditions, such as distress and agitation. A valid tool measures the condition for which it is intended. Reliability refers to the tool’s ability to consistently score pain each time the tool is used, test-retest reliability and when different people use the tool has interrater reliability.
However, a tool that is highly valid or reliable in measuring pain in the newborn may be difficult or too cumbersome to use in the clinical setting. Therefore, when selecting a pain assessment tool, family physicians should review the validity and reliability of various tools and determine the clinical utility relative to their own practice setting. Until more precise tools that are easy to use in the clinical setting are identified, existing pain assessment tools provide the best available mechanism to compare behaviors before, during, and after a painful procedure.60
Using a pain assessment tool that is multidimensional provides the clinician with the most information. Whichever tool is used, however, the measurement of infant pain is just one aspect of comprehensive pain assessment. The family physician should take a holistic view of the
34 patient, understanding that one score on a pain tool is not necessarily representative of the extent of that infant’s pain. Several objective Scales have been studied including:
2.5.1 NEONATAL INFANT PAIN SCALE.62
Neonatal infant pain scale [NIPS] scores, which scores behavioural signs of pain, facial expression, cry, breathing patterns, arm and leg reflexion and state of arousal. Measurement of physiological pain indices is not included in the NIPS tool.62
2.5.2. NEONATAL PAIN AGITATION AND SEDATION.
Neonatal Pain Agitation and Sedation [N-PASS], scores cry, irritability, facial expression, extremities tones and vital signs (heart rate, respiratory rate, blood pressure, oxygen saturation) to assess the infant’s response to stimuli.
2.5.3. NEONATAL FACIAL CODING SYSTEM.
Neonatal facial Coding System [NFCS], assesses nine facial features for pain response, Facial actions comprising the scale are brow bulge, eye squeeze, nasolabial furrow, open lips, mouth stretch (horizontal and vertical), lip purse, tongue tautening, and chin quiver. However, facial activity increases with gestational age and may not reflect premature infant pain.
2.5.4. POST-OPERATIVE COMFORT SCALE.26
Postoperative Comfort Scale is an assessment tool to measure postoperative pain in infants one to seven months old. An evaluation of ten behaviours (Sleep during preceding hour, Facial expression of pain, Quality of cry, Spontaneous motor activity, Spontaneous excitability, responsiveness to ambient stimulation, Flexion of fingers and toes, Sucking, Global evaluation of tone, Consolability and Sociability (eye contact) ) is accomplished with a score of 0, 1, or 2 for each. A total score of 15 to 20 is considered to indicate adequate postoperative pain management.
35 2.5.5 PREMATURE INFANT PAIN PROFILE.97
The Premature Infant Pain Profile (PIPP) is a pain assessment tool used frequently in research.
The PIPP combines behavioural, physiological, and gestational age data to arrive at a pain score or profile and is considered a reliable and valid instrument in a large data set.97 Components of the PIPP include gestational age, heart rate, oxygen saturation, behavioral state, and three components of the face; brow bulge, eye squeeze, and nasolabial furrow. Taking gestational age into account, the PIPP accommodates the recognition that the youngest and smallest infants may not be able to mount or sustain a response to pain in the same fashion as an older infant.
Therefore, these infants are given points toward their overall profile based on their gestational age.
This seven-item, four-point profile contains the components that appear to correlate with pain, but may not be specific or sensitive to pain. In addition, this tool can be challenging to use in the clinical setting because it requires observation before, during and after handling the infant and mathematical calculations regarding heart rate and oxygen saturation changes.63
Oxygen saturation changes and heart rate are measured with pulse oximeter. It reports the amount of oxygen currently carried by arterial blood as a percent of the maximum amount the blood can carry. An oximeter probe is typically clipped to a finger or ear lobe, or is attached to the body with adhesive. It has a sensor that measures the light passing through the skin and reports the saturation and pulse rate, either displaying or printing the reading. Basically, a saturation of 97% of the total amount of hemoglobin in the body is filled with oxygen molecules.
A range of 96% to 100% is generally considered normal. Anything below 90% could quickly lead to life-threatening complications.
36 2.5.6 THE CRIES.64
CRIES, which scores Crying, Requirement of oxygen saturation, increased vital signs, facial
Expression and Sleeplessness. The CRIES, developed for use with preterm and term infants undergoing postoperative pain, was initially tested on 24 infants who ranged in age from 32 to 60 weeks gestation. The CRIES is multidimensional and measures crying, oxygen requirements, increased vital signs, expression, and sleeplessness. 64
2.5.7 THE FLACC.56
The FLACC (Face, Legs, Activity, Cry, and Consolability) Pain Assessment Tool has been shown to have high inter rater reliability and evidence of validity in infants 2 months to 7 years of age. Because the healthy term newborn is not generally observed continuously using pulse oximetry or cardio respiratory information, this tool may be useful in the normal newborn nursery because its emphasis is on behavioral responses associated with pain and does not include physiological responses.56 The following points should be considered to ensure appropriate and comprehensive pain assessment: Pain measurement is only one piece of a comprehensive pain assessment that should occur within the context of each infant’s condition and environment. The lack of a response to pain in the preterm infant does not necessarily indicate lack of pain. A multidimensional tool, that is, a pain assessment tool that measures behavioral and physiological indicators of pain and ideally, one that has been tested for reliability and validity in the target population, should be selected.65
2.6 PAIN MANAGEMENT IN NEONATES.
Notwithstanding a growing body of knowledge about the physiology of neonatal pain, the evolution of neonatal pain assessment tools, and pain management guidelines, there persist a wide variety of opinions among health care providers about how to treat pain in our most vulnerable patients. Newborns feel pain and require the same level of pain assessment and
37 management as adults. Untreated pain in neonates may result in increased morbidity and length of stay in the neonatal intensive care-unit, exaggerated responses to pain in later life, and altered psychosocial development.
Even the healthiest of newborns may suffer the consequences of untreated pain. In spite of the growing evidence that untreated pain is costly to the neonates, a survey of pain management practices demonstrated that clinicians lack commitment to institute consistent pain management techniques.61 This may be due in part to the side effects experienced with the use of narcotics, the most common pharmacologic intervention used to treat pain.66
Prevention of pain whenever possible is the best approach to pain management in neonatal circumcision and other painful pain procedures during the neonatal period. When prevention is not possible, painful procedures can be minimized by limiting the number of blood draws required to safely monitor the infant, suctioning the infant on an as needed basis versus a routine protocol, and utilizing the most skilled person to perform painful procedures. 66 The method by which the family physicians perform specific procedures also can limit the pain experienced by the newborn. For example, venipuncture is usually more expeditious and less painful than blood sampling via heel stick in healthy full term infants.67
Regarded less of the best preventive approaches, painful procedures such as neonatal circumcision and venipuncture occur in neonates without anaesthesia. Treating newborn pain involves both pharmacologic and non pharmacologic methods. Acute pain, such as that following major surgery, is most commonly treated with narcotics, including morphine and fentanyl.
Sedatives, such as benzodiazepines, do not treat pain but are often used as adjuvant therapy to treat distress and agitation in combination with the narcotics used specifically to treat pain.
38 Although the pain experience in the Neonatal intensive care unit of preterm infants and term infants who are at risk of painful procedures has been the focus of many studies, healthy newborns also experience painful procedures that are frequently undertreated. Until recently, the most common neonatal surgical procedure, circumcision, was performed without anesthesia.68
To deal with the need for guidelines on treating the neonatal pain and stress experienced during circumcision, the International Evidence-Based Group for Neonatal Pain published a consensus statement. This consensus statement detailed the need to proactively treat neonates undergoing procedures known to be painful and to consider background analgesia such as a low dose morphine drip for those infants requiring mechanical ventilation .62
The International Evidence-Based Group for Neonatal Pain, demonstrated in a pilot trial that low- dose analgesia (morphine) administered to infants at 24-32 weeks gestation who were ventilator dependent improved neurologic outcome, specifically a reduction in severe intraventricular hemorrhage (IVH). Sixty-seven preterm infants, 24-32 weeks gestation were randomized to receive either continuous infusions of morphine sulfate, midazolam or placebo. Infants who received the morphine continuous infusion had improved neurologic outcome when compared with the infants who received the midazolam and placebo infusions. The authors speculated that the background analgesia provided by morphine continuous infusion reduced the acute cardiovascular changes associated with common painful procedures such as endotracheal suctioning which can increase intracranial pressure and result in IVH.69
Although there are published guidelines, research findings and consensus statements about management of pain, yet there is no remarkable variation in the management of pain in neonates. Even though most clinicians now believe that neonates feel pain to at least the same
39 degree as adults, reliable application of techniques to manage newborn pain is lacking. Several international surveys have revealed that analgesia is used infrequently before procedures and that neonates who are awake frequently receive no sedation prior to endotracheal intubation.70
Family physicians should be aware of newborn pain management guidelines and implement treatment strategies consistently in their patient care settings to ensure appropriate pain management.71
2.6.1 PHARMACOLOGICAL MANAGEMENT.
2.6.1.1 MORPHINE.
Morphine is an extract of opium, commonly used to treat severe pain not only in newborns but also in patients of all ages. The prototype opioid, morphine works to relieve pain by stimulating the Mu-opioid receptors in the spinal cord. Side effects may include respiratory depression, apnea, hypotension, and urinary retention.72
2.6.1.2 FENTANYL.
Fentanyl is used to treat moderate to severe pain, is a synthetic opioid much more potent than morphine. Because of its high lipid solubility, Fentanyl is widely distributed into body tissues.
Reported side effects during a bolus administration of Fentanyl include bradycardia, hypotension, and chest-wall rigidity. These effects can be minimized with slow administration time and close observation. Use of Fentanyl is more likely to result in rapid drug tolerance and withdrawal symptoms when compared with Morphine.73
There is sparse research to suggest that one narcotic is preferred over another for pain management. Researchers reported improved neurologic outcomes with continuous morphine infusions for infants on mechanical ventilation when compared with midazolam and placebo infusions. However, other researchers compared the effects of fentanyl and morphine during the
40 first 2 days of life in newborns on mechanical ventilation and concluded that fentanyl had fewer side effects and may be superior short-term analgesia.73
2.6.1.3 SEDATIVES.
Many clinicians have used benzodiazepines as an adjunct to narcotic administration for the treatment of both pain and agitation in critically ill infants on ventilatory support. Benzodiazepines such as diazepam and midazolam are used to treat agitation, but do not treat pain. Diazepam is a potent sedative with a long half-life of 20-80 hours. Disadvantages of using diazepam include the development of tolerance and potential displacement of bilirubin from binding sites. Another example, midazolam, may be preferred by some clinicians because its half-life is only 1-3 hours, with potent sedative effects. Disadvantages of using midazolam include apnea, hypotension, and abnormal movements.74 Although benzodiazepines provide sedation and amnesia, they also can mask the common behavioral signs of pain and therefore should not be used alone for the treatment of pain.75 A recent collaborative review concluded that midazolam is not recommended for use as a sedative in preterm infants because adequate scientific evidence is lacking.76
Although used frequently, benzodiazepines have not been widely studied and their effects on the newborn may be unknown.76
2.6.1.4 TOPICAL MEDICATION.
Topical medications such as Eutectic Mixture Local Anaesthesia cream also have been used for minor procedures such as venipuncture and lumbar puncture.
2.6.2 NON-PHARMACOLOGIC MANAGEMENT.
2.6.2.1 ORAL SUCROSE.
The use of oral sucrose for the treatment of brief, mild, procedural pain has been described for over 10 years.77 Although the ideal dose, concentration, and administration method of oral sucrose are unclear, its effectiveness in treating pain from heel sticks and venipunctures is compelling.78 In fact, the AAP and Canadian Pediatric Society recommend the use of oral
41 sucrose to manage procedural pain during heel stick, venipuncture, and intramuscular injection.
A meta-analysis revealed that a dose of 1 to 2 ml of a 24% sucrose solution administered approximately 2 minutes before a minor procedure is effective in treating pain from mild, brief procedures.79
Oral sucrose also has been studied extensively for use as analgesia during circumcision. A research by Stevens et al demonstrated that sucrose on a pacifier may be an effective method of analgesia for circumcision when the dorsal penile nerve block is not desirable.79 Oral sucrose and other sweet-tasting substances appear to work by way of an endogenous opioid-mediated pathway via the sweet taste buds located on the anterior portion of the tongue. This pain relief effect is reversed by administration of naloxone hydrochloride, a narcotic antagonist, affirming that the pain effect may be modulated by endogenous endorphin release. Additionally, a pacifier dipped in the oral sucrose solution appears to promote nonnutritive sucking, which provides an additional calming effect.77 Administration of oral sucrose via the anterior portion of the tongue is an important component of its effectiveness. For example, one study showed that administration via nasogastric tube had no effect. Although, the evidence is not complete for sick, preterm infants especially in relation to multiple doses, the use of oral sucrose for mild procedural pain, heel stick, venipuncture and IM injection fentanyl is evidence-based. To date, there are no known short term side effects to the use of oral sucrose with appropriate administration.78
Studies evaluating the effectiveness of oral sucrose as a pain management strategy also used pacifiers as either the method of administration or as an adjunct. A study found that use of a pacifier provides some analgesia, but is not as effective as oral sucrose administration combined with sucking on a pacifier. Use of a pacifier is an effective adjunct to pain management strategies and is easy to implement.83
42
2.6.2.2 NON-NUTRITIVE SUCKING.
Other non pharmacologic approaches to pain management include use of nonnutritive sucking, music, and holding and rocking. Nonnutritive sucking as a pain-relieving technique has been studied extensively and shown to be helpful in reducing crying time and heart rate during painful procedures such as circumcision and heel stick.80
2.6.2.3 MUSIC.
Music therapy (MT) to modulate pain during invasive procedures has been less studied. Butt and
Kisilevsky in 2000 demonstrated MT as an effective noninvasive intervention to treat pain during a heel stick procedure in 14 preterm infants. Although this was a small study, the researchers demonstrated that infants of more than 31 weeks of Post conceptional age responded best to
MT, with a rapid return of heart rate, behavioral state, and facial expressions to baseline levels as compared with infants less than 31 weeks of Post conceptional age. Another small study by
Bo and Callaghan in 2000 demonstrated an effective reduction in pain behaviors and improvement in transcutaneous oxygenation levels in infants receiving MT.81
2.6.2.4 HOLDING AND ROCKING.
Holding, rocking, and skin-to-skin contact have been shown to effectively modulate the pain responses of newborns during a heel stick procedure. Gray at el in 2000 demonstrated that the holding of term newborns skin-to-skin by their mothers during a heel stick procedure markedly reduced crying and grimacing.82 Gray at el in 2002 in another recent study revealed that infants held by their mothers or breastfed before, during, and after a heel stick procedure had lower pain scores when compared with those who were not. The researchers could not determine which intervention, suckling or skin-to-skin contact, was responsible for the reduced pain expression.
43 2.7 ANAESTHESIA FOR NEONATAL CIRCUMCISION.
There is disagreement among physicians about using anesthesia during circumcisions. Prior to the mid-1980s, anesthesia was not used because infant pain was not acknowledged by the medical community. That belief has changed among many physicians, but local anesthetic injection, the best option tested still is not typically administered due to a lack of familiarity with its use, as well as the belief that it introduces additional risk.84 Although there is indication that the risk is minimal, most physicians who perform circumcisions do not use anesthesia even after they are taught how to use it. When anesthesia is used, it relieves only some but not all of the pain, and its effect wanes before the post-operative pain does. Because no experimental anesthesia has been found to be safe and effective in preventing circumcision pain, research in this area continues.
In a recent study by Taddio et al on the subject, the researchers described circumcision without pain relief as barbaric.82 Taddio wrote that subjecting an adult to the same practice would be unfathomable.83 Until recent times a majority of neonatal circumcisions were performed without local anaesthesia. Stated justifications for not using anaesthesia include a belief that circumcision causes minimal pain. That rapid expert circumcision causes less pain than that engendered by local anaesthetic procedures and that newborns have no memory of pain.84
There are good experimental data to refute the first two of these contentions and, even though the third suggestion cannot be considered a sufficient reason to withhold anaesthesia, there is an emerging body of evidence to show that painful neonatal experiences do have long term consequences, even if not rooted in conscious memory.79 Researchers reported that circumcised boys had higher pain and cry scores during routine immunization at 4-6 months of age than uncircumcised boys and scores were again higher if circumcision was unaccompanied by local anaesthesia compared with those receiving topical anaesthesia.68,75 Newborn infants subjected
44 to a variety of noxious stimuli have hormonal, physiological and behavioural responses.82 There have been two recent consensus statements on the prevention and management of pain in the newborn which should be used to guide the clinical approach to anaesthesia for circumcision.
Both statements emphasized that compared with older age groups newborns may experience a greater sensitivity to pain, such pain may have long term consequences, and a lack of behavioural response for example lack of crying does not necessarily indicate a lack of pain.
While general anaesthesia will often be used for circumcision beyond the neonatal period it has rarely been considered as an option for newborn circumcision.85
When local or regional anaesthesia for newborn circumcision is used, the following has been provided: local application of a eutectic mixture of local anaesthetics (EMLA cream), dorsal penile nerve block (DPNB), penile ring block (PRB) and caudal epidural block. 83
2.7.1 EUTECTIC MIXTURE OF LOCAL ANAESTHESIA (EMLA cream).
EMLA cream (5% lidocaine/prilocaine) reduces pain during circumcision and blood sampling in newborn babies but is less effective than the others. Rises in met-hemoglobin 3.5 to 13 hours after application of EMLA cream are well below potentially harmful levels. In a double-blind, randomized, placebo-controlled trial there was no change in met-hemoglobin concentration after
EMLA cream. Epicutaneous EMLA is more effective than 30% lidocaine. Lidocaine 4% cream has similar efficacy as EMLA.83
2.7.2 DORSAL PENILE NERVE BLOCK (DPNB).
Dorsal penile nerve block represents 85% of anaesthetic use in the USA and is effective, even in low birth weight infants. It involves injection of local anesthetic at the 10 and 2 o’clock positions at the base of the penis, where the dorsal penile nerve is situated. Allowing the infant to suckle from a gloved human finger further decreased measured pain responses during dorsal penile nerve block. The method is regarded as useful, with a failure rate of only 4–7%, a very low
45 incidence of complications, which if they occur tend to be minor. An isolated report describes an extremely rare case of ischemia in the hours after an adult circumcision and this could be reversed quickly and simply.84
2.7.3 PENILE RING BLOCK (PRB).
Ring block, which had initially been used for post-circumcision analgesia, is simpler, and extremely effective. This procedure involves injection of a local anesthetic around the circumference of the penis at the mid-shaft level. In fact ring block may be the best. Pain from the infiltration of a local anesthetic is short-lived and significantly less than the pain from an un- anaesthetized circumcision.85
2.7.4 PACIFIERS.
Pacifiers, especially with glucose or sucrose, are also effective (pain score = 1 as opposed to 7 with placebo). Infants circumcised with the Mogen clamp and combined anesthesia (lidocaine dorsal penile nerve block, lidocaine-prilocaine, acetaminophen, and sugar-coated gauze dipped in grape juice), with 55 seconds taken for the procedure, showed substantially less pain than those circumcised with the Gomco clamp and EMLA cream, which took 577 seconds for the procedure. Music can also be used for pain relief.
Recent trials have demonstrated that combined analgesia and local anaesthesia for example, pre- and post-operative paracetamol, EMLA cream to the abdomen and foreskin, oral sucrose, and DPNB or PRB75, are more effective than either alone.86
According to a study, anaesthesia is used by 45% of physicians performing infant circumcisions.87 Dorsal penile nerve block was the most commonly used form. Obstetricians were notable in the study for a significantly lower rate of anaesthesia use (25%) than pediatricians (71%) or family practitioners (56%). A 2004 Cochrane review concluded that dorsal
46 penile nerve block is the most effective form of anaesthesia, while EMLA (topical anaesthesia) was less effective. The authors noted that both anesthetics appear safe, but neither of them completely eliminated pain.87
2.8 COMPLICATIONS OF NEONATAL CIRCUMCISION.
It is imperative to review the normal development of the phallus to better comprehend both the circumcised and uncircumcised state. During the third month of intrauterine development, a fold of skin develops at the base of the glans and begins to grow distally. This fold ultimately becomes the prepuce. The dorsal aspect of the fold grows more rapidly than the ventral, so at first only the dorsum is covered. As the glanular urethra closes, so does the ventral prepuce. The resultant ventral fusion of the prepuce is marked by the frenulum. Preputial development is usually complete by the fifth month of intrauterine life. Once the glans is completely covered, the inner surface of the prepuce and epithelium of the glans itself, both of which are stratified squamous in type, fuse. Later in gestation, presumably under the presence of androgens, the squamous cells begin to keratinize and to arrange themselves in whorls. The whorled cells then degenerate so that clefts appear between the prepuce and the glans. These clefts increase in size and fuse with each other, as a result of which the inner preputial epithelium and the epithelium of the glans eventually are separated one from the other. This separation is usually incomplete at birth and continues through childhood. In infants and toddlers a mild, transient inflammatory reaction may occur at some stages of this separation process.87
At birth the prepuce is retractable in only four per cent of boys. In almost half of newborn boys it cannot be retracted sufficiently to permit one to visualize even the external urethral meatus. By six months of age, the prepuce can be retracted in only twenty per cent of boys; by three years of age ten per cent of boys still have an unretractable foreskin. However, the foreskin is completely retractable in almost all boys by seventeen years of age. Complete separation of the foreskin
47 from the underlying glans, even if the prepuce is partially retractable, has occurred in only thirty- seven per cent of six-year-old boys. Smegma can be found in the preputial cavity in one per cent of uncircumcised six-year-old boys, but the presence of smegma increases so that it is demonstrable in about eight per cent of uncircumcised sixteen-year-old boys.87, 88
Complication may follow circumcision just as with any other surgery.
2.8.1 REMOVAL OF TISSUES.
Circumcision lends itself to errors in that either inadequate or excess tissue can be removed.
Several different problems may result depending on which combination of circumstances is extant. The simplest problem is cosmetic only. When insufficient skin and inner preputial epithelium are removed and the new preputial orifice does not fibrose, the cosmetic appearance is such that the penis does not appear to have been circumcised. Although this result poses no medical threat, the affected individuals’ parents often are quite upset with the result. If inadequate skin and insufficient inner preputial epithelium have been removed, and in addition, there is contraction or fibrosis of the preputial ring, true phimosis can be produced. This occurred in two per cent of patients in one series. This complication often can be severe and may result in urinary obstruction.
Removal of too much skin from the penile shaft may be caused by pulling it over the glans during operation. After foreskin excision the remaining skin slides back, leaving a denuded shaft. Others suggest that such penile denudation injuries occur as a result of failure to break down the ventral foreskin adhesions to the glans penis completely.88 It is therefore essential that, before any incision is made, the inner preputial epithelium be completely free from the glans such that the entire coronal sulcus can be visualized.
48 The majority of cases can usually be managed conservatively with a satisfactory cosmetic and functional outcome.89, 90 Such injuries in adults may be managed conservatively if the defect is less than half of the total penile skin. Complete denudation in the adult is managed by split- thickness skin grafting for optimum cosmetic and functional results. Of three cases encountered by a researcher, one child with complete denudation had initial treatment by burial of the penis in a tunnel of scrotal skin; no follow-up was available on this patient.89 Use of a pedicle scrotal skin flap has recently been described for the reconstruction of penile shaft skin.90
A rare consequence of excision of excess preputial skin is the so-called concealed penis. A study maintains that, although an excess of skin is removed, not enough inner preputial epithelium is excised.91 The new preputial orifice is therefore, distal to the glans, and as healing and fibrosis occur the penile shaft is forced into the suprapubic fat, with resulting preputial ring at the level of the skin of the mons pubis. Other suggestions about the aetiology of this complication include a tendency of the penis to retract into the mons pubis and the possibility that the penile shaft is forced into a subcutaneous position by wound contraction. Subsequent fibrosis of the circumcision wound leads to stenosis of the preputial orifice, which then traps the penile shaft subcutaneously.92
Prevention of all of these errors are best achieved by marking the site of the corona on the skin surface prior to any incision and by completely freeing the inner preputial epithelium from the glans and thereby visualizing completely the coronal sulcus before applying any clamp or excising any tissue. Treatment of any problems that result because insufficient prepuce has been excised requires repeat circumcision. When phimosis exists with a concealed penis, the initial incision for this circumcision should be circumferential and at the preputial ring so that the excess inner preputial epithelium can be used in the repair.
49
By using this type of incision rather than a dorsal slit, one may be able to avoid the need to use skin grafts for coverage of the penile shaft. In the treatment of those cases in which excess skin has been excised and skin grafts are necessary, the use of free full thickness grafts of hairless skin or split thickness skin grafts is preferable to burying the penile shaft in the scrotum or under the abdominal wall with delayed removal and use of scrotal skin because the former technique produces superior cosmesis. In the presence of phimosis, a study recommends a circumferential incision at the preputial ring to avoid the need for skin grafts to achieve coverage of the penile shaft. A vertical incision caudal to the circular scar was used to expose the glans and penile shaft which was in a subcutaneous position, tightly adherent to the surrounding tissue. Nearly complete direct skin coverage was achieved, apart from a small ventral defect which was covered by rotation of the scrotal skin.81
Many other forms of surgical mishaps have been reported. Laceration to the penile skin and scrotum resulting in exposure of both testes as reported by a study, and was managed by primary suturing. Laceration of the penile shaft with resultant partial amputation has also been described. Total ablation of the penis may occur as a result of diathermy injury, and loss of the penis from the use of a rubber band as a tourniquet has been reported, injury to the glans may result from inadequate separation of preputial adhesions. Glandular injury may be of varying severity and cases of complete surgical amputation of the glans have occurred. A study described a case in which inadvertent placement of scissors into the urethra while attempting a dorsal slit resulted in surgical bivalve of the glans.93
2.8.2 HAEMORRHAGE.
Haemorrhage, remains the commonest complication encountered during and after circumcision.
In the majority of cases bleeding is minor and all that is required to achieve haemostasis is
50 applying gentle pressure on the area. Excessive bleeding may be due to anomalous vessels or to the presence of a bleeding disorder. In the event of a bleeding disorder, appropriate clotting factors may have to be administered.94
Pharmacological agents may also be used to stop minor troublesome bleeding and in this respect the application of a 1:100 000 adrenaline solution is not uncommon. Although there is a slight danger from systemic absorption, at this low concentration complications are unlikely. If a more concentrated solution is used, however, there is greater systemic absorption with its attendant problems. A study described four such cases in which a sponge-soaked solution of
1:1000 adrenaline was sprayed on the bleeding area of the frenulum after circumcision. The patient developed tachycardia, acrocyanosis and local pallor of the penis. After subcutaneous injection of phentolamine (an alpha-adrenergic receptor antagonist) at the base, shaft and corona of the penis, all penile pallor disappeared and the systemic signs abated.95
Alternatively obvious bleeding vessels may be ligated with a fine suture. One of the commonest sites for persistent bleeding is at the frenulum, and in this area it is not uncommon to insert a haemostatic suture. However, because of the close proximity of the underlying urethra, it is easy for such a haemostatic stitch to be placed in the urethra itself. The result is development of a urinary fistula. Avoidance of this complication depends on meticulous technique when suturing around the frenulum and in taking superficial tissue only in the stitch.
2.8.3 INFECTION.
Infections occur after circumcision, as in any surgical procedure. The incidence of infection in one series of neonatal circumcisions was 0.4 per cent, while in a series of older boys it was as high as 10 per cent.96 In the majority of cases this is usually mild and manifested by local inflammatory changes, but occasionally there is ulceration and suppuration. Most infections are
51 of little consequence and settle with local treatment. Occasionally, however, sepsis may have more alarming consequences and may even cause death.
The perineal skin is heavily colonized by both normal skin saprophytes and by bowel flora and it is surprising that significant septic complications do not occur more frequently.97
Infection and bleeding are by far the most common complications. These are less likely with a skilled and experienced circumciser. Infections are usually minor and local, but in some cases they have led to urinary tract infection, life-threatening systemic infections, meningitis or death.94
Staphylococcal infections are a growing problem in hospitals for any operation. Some research has found a statistically significant relationship between Staphylococcus aureus infections and whether an infant has been circumcised.95 Boys have been found to be far more susceptible to staphylococcal infections than girls because the freshly circumcised penis is a major site for highest concentration of staphylococcus and the blood provide an excellent media for growing bacteria that have infected the circumcision wounds.87,88 Oral suction is practiced by a minority of
Jewish circumcisers. It has been linked with 8 cases of herpes infection in Israeli infants.
2.8.4 URETHROCUTANEOUS FISTULA.
Urethrocutaneous fistula following circumcision may occur for a variety of reasons but, fortunately the reported incidence of this complication is low. Perhaps the commonest cause is a poorly placed suture at the frenulum in an attempt to obtain haemostasis. This results in strangulation and necrosis of part of the urethral wall, with resultant subglandular fistulation not dissimilar to glandular hypospadias. Fistulation may also occur as a result of sepsis or unrecognized rare penile anomaly, such as megalourethra.
However, many other fistulas arise from using the Plastibell device or Gomco clamp. Although the mechanism of injury is not clear it is probable that urethral injury results from crushing by the
52 device. Most of these fistulas open on to the dorsum of the penis, but they may open to the ventral surface, an anatomical arrangement not dissimilar to that seen in epispadias. Such a case was reported following surgical bivalve of the glans. Although there are many approaches to the management of such a urethral fistula, appraisal of the techniques employed is beyond the scope of this review.99
2.8.5 MEATAL STENOSIS.
Meatal stenosis is generally a direct consequence of circumcision that is seldom encountered in uncircumcised men; meatal calibre is known to be greater in uncircumcised individuals. The incidence of meatal ulceration following circumcision is from 8 to 20 per cent.86 The aetiology is thought to be irritation of the external urethral meatus by ammoniacal substances present in wet sodden nappies.96,97 Such irritation is unlikely in the presence of a normal prepuce, which serves to protect the glans from these irritant substances. In a prospective study by Yazici et al of 140 consecutive neonatal circumcisions, there was a 20 per cent incidence of meatal ulceration within the first 2-3 weeks after circumcision.100 It is thought that meatal ulceration after circumcision is the initiating event in a vicious cycle of stenosis and ulceration, followed by more stenosis. Meatal stenosis following circumcision has been advanced as a cause of recurrent pyelonephritis and obstructive uropathy, for which meatotomy is curative.100
2.8.6 URINARY RETENTION.
Urinary retention has been reported following circumcision, usually secondary to a tight circular bandage, and obviously is best treated by removal of the bandage. In addition, urinary retention secondary to a tight bandage presumably sets the stage for urosepsis in some of the reported cases of systemic infection following circumcision. When tincture of benzoin is used in or as a dressing for circumcision, it may occlude the urethral meatus and produce urinary retention.
Hesitancy and dysuria are seen following circumcision in as many as 60 percent of older boys.95
53 2.8.7 CHORDEE
Chordee can be produced by circumcision, especially if the procedure is performed at the time of acute inflammation. This chordee usually is produced by a dense scar on the ventrum of the penis, and a Z-plasty often suffices for its resolution.96
2.8.8 GLANDULAR EPITHELIUM
The glandular epithelium may be denuded by a less than gentle technique when separating the preputial adhesions and this may be exacerbated if the glans is held firmly by a gauze swab. The glans may then be more prone to local sepsis with the resulting formation of a scab. Fortunately, most settle spontaneously with attention to hygiene. 96
2.8.9 SKIN BRIDGE
A skin bridge may develop between the glans and the penile shaft. This may tether the erect penis so producing pain and deformity. Smegma often accumulates under those skin bridges.
The aetiology of this condition remains unknown, although injury to the glans at the time of circumcision or incomplete separation of the inner preputial skin has been advanced as possible factors. The treatment of such bridges is simple surgical division
2.8.10 NECROSIS
Necrosis and slough of the glans or even entire penis has been reported following circumcision.
Distal ischemia producing such tissue loss may result from infection, from the use of solutions containing epinephrine, from vigorous attempts at haemostasis with suture or cautery, from the prolonged use of a tourniquet, or from a tight bandage. Necrosis is particularly likely to result if cautery is applied directly to a circumcision clamp (e.g., the Gomco). When the entire penis is lost following such a misadventure, it usually is best to change the child's sex of rearing to female. Such changes are particularly successful when accomplished before eighteen months of age. Surgical reconstruction along female lines is far simpler and eminently more satisfactory in such circumstances than is reconstruction of a phallus.
54
2.8.11 INCLUSION CYST
Inclusion cysts following circumcision have been described. That reported by a study was found histologically to be an epidermal cyst.93 It is possible that cysts also arise as a result of preoperative implantation of smegma. The use of silica talc on surgical gloves has been associated with the formation of granulomas and such a lesion was described in a circumcision wound fifteen years after the original surgical procedure.93
2.8.12 LYPHOEDEMA
Although penile lymphoedema following circumcision has been reported, there is a paucity of information regarding the aetiology and management of such a problem and accounts in the literature are anecdotal.89 The degree of penile oedema may be greater with the Plastibell device.
2.8.13 HYPOSPADIAS/EPISPADIAS
Both hypospadias and epispadias have inadvertently been produced during circumcision by splitting the glans penis at the time of dorsal or ventral split preparatory to actual excision of the prepuce. The operator can prevent this complication by visualizing what is done rather than by performing some aspect of the procedure blindly. On rare occasions the penile or scrotal skin has been inadvertently lacerated. These lacerations probably result from carelessness but rarely are of any consequence. On occasion, the tip of the glans has been excised, usually when the operator was using a blind technique. Hypospadias remains a contraindication to circumcision, as surgical reconstruction may require the use of all available penile skin.
2.8.14 PLASTIBELL MIGRATION
When the Plastibell is utilized, the ring of the bell may migrate and by pressure necrosis produce a set of problems unique to this technique. If the ring is too large it may migrate proximally and
55 produce a groove in the shaft itself. To avoid such complications, any retained Plastibell ring should be removed after several days if it has not fallen off spontaneously.
2.8.15 IMPOTENCE
Impotence has been observed following circumcision. A study described two cases both of which were associated with injection of 1 per cent lidocaine directly into the corpora after application of a rubber band at the base of the penis to act as a tourniquet.101 As 10 - 15 ml anaesthetic was used this perhaps resulted in a fifty per cent mixture of lidocaine and blood in direct contact with the vascular endothelium of the penis. It is postulated that this high concentration irreversibly damaged the endothelium of the corpora cavernosum with resulting impotence. Impotence followed partial amputation of the penis at circumcision, despite plastic reconstruction, in a case reported by a study.100
2.8.16 ANAESTHESIA COMPLICATIONS
Anaesthesia or lack of it may produce complications. General anesthesia led to deaths related to circumcision in at least one study. Caudal anesthesia is currently being employed in some centers. Its use, like the use of all regional anesthetics has its own inherent complications. When local anesthetic agents are injected into the corpora cavernosa, they can injure the tissues, producing impotence as previously noted. Additionally, idiosyncratic reactions and overdosages can occur. Solutions containing epinephrine may produce local tissue problems or systemic toxicity. The performance of neonatal circumcision without anesthesia produces decreased Po2, increased serum cortisol, and withdrawal, all indirect evidence of pain. Additionally, circumcision without anesthesia in a newborn has precipitated a pneumothorax.
2.8.17 CARCINOMA OF THE PENIS
Carcinoma of the penis following circumcision appears to have a different natural history from cancer in uncircumcised men. Whereas penile cancer in the uncircumcised tends to arise on the glans or prepuce, after circumcision the tumour is likely to develop in the surgical scar. Such
56 tumours occur mostly on the penile shaft and tend to spread locally with distant metastasis as an infrequent or late occurrence. Surgical excision is the treatment of choice, as neither radiotherapy nor chemotherapy appears to be effective. Nearly all of these cases have been reported from Saudi Arabia, where there existed a radical form of circumcision that was practiced by the tribes in the southern regions. The circumcision included excision of the skin in the suprapubic region with a longitudinal incision extending between the anterior iliac spines. This practice is now prohibited.102, 103
2.8.18 PSYCHOLOGICAL ISSUES
According to Freudian theory, by the fourth or fifth year of life the genital concentration of all sexual excitement is achieved and the boy's interest in the genitals attains a dominant significance, the phallic stage. For a child at the phallic stage this fear that something might happen to his prized organ is called castration anxiety. Such psychological sequalae are not confined to the young child. Circumcision performed in the neonatal period is associated with marked behavioural changes that may last up to 24 hours; supporting this observation is the finding of a rise in both serum cortisol and cortisone levels after neonatal circumcision.
Circumcision in the neonate has been noted to increase both respiration and heart rate, and is associated with a significant fall in transcutaneous oxygen tension. Allied to this is a change in sleep pattern with prolonged non-rapid eye movement sleep. This change has been interpreted as being consistent with a theory of conservation - withdrawal to stressful stimulation.101
Circumcision can cause dysmophophobia, and in a study by Jin et al reported a case of genital self-mutilation in a non-psychotic patient who attempted to reconstruct the foreskin himself.91
Two groups of men seeking restoration of the foreskin have been identified. First is a group of
Jewish men who sought to disguise their religious identity during times of political crisis. Second is a group of homosexuals whose circumcised status is associated with unwanted masculinity
57 and anger over having no choice over their circumcision. Genital mutilation by attempted circumcision has been reported after paternal death in two patients, both of whom exhibited features of acute psychosis. Schizophrenia following elective circumcision has also been reported.102
In societies in which circumcision is intricately linked to tradition and culture, the uncircumcised individual is likely to be an outcast. This prejudice may be great enough for uncircumcised men not only to be ostracized by their peers but even to be attacked and beaten for their lack of conformity. Such beatings in men refusing to be circumcised have occurred in the Xhosa tribe of
South Africa and, in one instance, the attack was violent enough to result in the development of crush syndrome.104 Some also argue that anger over being circumcised as a child is also a complication of circumcision. 104
2.8.19 MEATITIS
The opening to the urethral meatus may also be affected, leading to meatitis, meatal ulceration and meatal stenosis. 104
58 CHAPTER THREE: MATERIALS AND METHODS
3.1 STUDY ENVIRONMENT
Plateau State Specialist Hospital is a 152 bed facility located in Jos, the State Capital. It is an accredited centre for postgraduate residency in Family Medicine, for both the National
Postgraduate Medical College of Nigeria and the West African College of Physicians. It offers a full complement of services in medicine, paediatrics, Obstetrics and gynaecology and general surgery. Other services include blood bank, human virology research laboratory and radiology. It serves as a referral centre for general, cottage and private hospitals in the state and neighboring states of Kaduna, Bauchi, Nassarawa, Benue and Taraba.
Jos is the capital of Plateau State in the North Central region of Nigeria. Its weather is cool all year round and it is endowed with beautiful landscapes which attract various Nigerian ethnicities to settle in the city.
Circumcisions are normally scheduled for Mondays and Fridays every week. The circumcisions were performed in the main theatre of the hospital, which is equipped with all necessary resuscitation equipment. The duration of the study was three months, from February to May,
2008.
3.2. STUDY POPULATION
All newborn male neonates, presenting for routine circumcision at the Plateau State Specialist hospital, Jos, Nigeria were considered for inclusion in the study.
3.3 STUDY DESIGN.
It was a randomized control study, comparing pain scores of circumcision with local anaesthesia
(experimental group) or without local anaesthesia (control group). A total of 72 neonates were
59 randomly assigned to the two groups; unanaesthetized group and a local anaesthesia group.
Computer generated random numbers were prepared and sealed in opaque unmarked envelopes containing group assignments. After a neonate was placed on the operating table, the envelope was opened to determine which group he belonged to. The neonates were not matched for age, weight, or socio-demographic characteristics.
3.4 THE SAMPLE SIZE.
The sample size was calculated using this formula 24
N = 4s2/d2.
Where N = minimum sample size
s = standard deviation of pain scores from a previous study.
d = size of the difference in means to be detected (i.e. precision of estimates).
A previous study7, gave
s = 0.9
The chosen size of the difference in mean pain scores to be detected in the 2 groups, d=0.3 at
80% power and 95% confidence level (alpha=0.05).
Therefore minimum sample size in each group,
N = 4(0.9)2/ (0.3)2 = 36.
Thus, 72 neonates, 36 in each group participated in the study.
3.5 SAMPLING METHOD.
Consecutive subjects presenting for circumcision and meeting the inclusion criteria were recruited after informed consent was obtained from the neonate's mother. Eligible subjects were then randomly assigned to either treatment arm by picking opaque unmarked envelopes containing random numbers and group assignments by the neonate’s mothers.
60 3.6 INCLUSION CRITERIA.
1. Full-term baby defined as delivery at a gestational age greater than or equal to 37 completed weeks.
2. Age- 48 hours to 30 days.
3. Weight greater than 2.5kg at birth or at presentation.
3.7 EXCLUSION CRITERIA.
1. Evidence of bleeding diathesis.
2. Sedation or pain medication within the previous 48 hours.
3. Local infection around the prepuce.
4. Urethral or penile shaft abnormality.
3.8 METHOD AND INSTRUMENT OF DATA COLLECTION.
All the anaesthetic procedures and the circumcisions were performed in identical manner by the principal investigator. All the circumcisions were done using plastibell technique.
The neonates in group one (anaesthesia group) was given local anaesthesia. The neonates in group two (no anaesthesia group) had no local anaesthesia given to them.
For the anaesthesia group, local anaesthesia was performed using 0.4 ml of 1% lidocaine without epinephrine. This was injected subcutaneously into the foreskin at both 10- and 2-o’clock positions at the level of the corona using a 26-gauge tuberculin syringe. Circumcision was performed after 5 minutes to allow the anaesthesia to take effect. For the group without anaesthesia, circumcision was performed without prior administration of local anaesthesia.
The neonate was restrained at the level of the thighs by straps allowing access to surgical field on a circumcision operating table in the supine position. The penis and the perineum were cleaned with diluted chlorhexidine.
61 The foreskin was grasped by two artery forceps at the lateral edges and pulled forward. An artery forceps was passed through the preputial orifice under the foreskin to lyse the adhesion between the glans and the skin.
The forceps were removed and a mark was made by crushing on the dorsal aspect of the foreskin. A dorsal slit was made between the glans and the foreskin. The bell of the plastibell was placed between the glans and foreskin. The foreskin was pulled slightly forward and clamped with artery forceps.
Suture material was then looped around in the groove and a surgical knot was tied firmly. The excess skin was excised with scissors. A probe was passed between the glans and the bell to remove clots of blood. The neonate was cleaned and handed to the mother.
The suture material cut off the blood supply to the foreskin which wither and drops off, taking the
Plastibell with it, in 7 to 10 days. Different sizes of plastibell were used for the circumcision on different neonates.
Recording of data was done by trained assistants using Neonatal/Infant pain scores (NIPS), and pulse oximeter which was attached to the right big toe. Data were recorded during the following phases:
Lateral clamping of the foreskin
Lyses of adhesions
Dorsal cutting, retracting the foreskin for further lysis of adhesions
The tying of the surgical knot
The removal of the excess skin.
Heart rate and oxygen saturation were continuously recorded throughout the procedure using pulse oximeter. The pulse oximeter was placed on the neonate's right big toe in all cases. The
62 pulse oximeter recorded the heart rate and oxygen saturation data continuously in wave form and in digital form at an interval of sixty seconds.
Mean heart rate and oxygen saturation were calculated from the digital output. The data was analyzed by an investigator who was blinded to the group assignments.
The pain scale consists of six behavioral components with composite scores of 0 to 6 (Appendix
C). Five out of the six components were used in this study. These included:-
Facial expression
Crying
Breathing patterns
Arm and leg movements
State of arousal
Leg movement was omitted because the infant was restrained on the theatre bed.
The pain scores (NIPS) was recorded as follows:
63 Neonatal/Infant Pain Scale (NIPS) 17 (modified)
(Recommended for children less than 1 year old)
Pain Assessment Score
Facial Expression
0 – Relaxed muscles Restful face, neutral expression
1 – Grimace Tight facial muscles; furrowed brow, chin, jaw, (negative facial expression – nose, mouth and brow) Cry
0 – No Cry Quiet, not crying
1 – Whimper Mild moaning, intermittent
2 – Vigorous Cry Loud scream; rising, shrill, continuous (Note: Silent cry may be scored if baby is intubated as evidenced by obvious mouth and facial movement. Breathing Patterns
0 – Relaxed Usual pattern for this infant
1 – Change in In drawing, irregular, faster than usual; gagging; breath Breathing holding Arms
0 – No muscular rigidity; occasional random movements of arms Relaxed/Restrained 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion
Legs
0 – No muscular rigidity; occasional random leg movement Relaxed/Restrained 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion
State of Arousal
0 – Sleeping/Awake Quiet, peaceful sleeping or alert random leg movement
1 – Fussy Alert, restless, and thrashing
N.B. Legs movement will be excluded because the infant will be restrained on theatre bed.
64
A total score of six or more indicated pain, while <6 indicated minimal or no pain. This response was used to judge the adequacy of the local anaesthesia. The beginning of the circumcision was recorded as the time the first clamp was placed on the foreskin. The end of the procedure was recorded when sterile drapes were removed. Neonatal infant pain scores (NIPS) were assigned for each of the five events on all neonates. Mean NIPS scores for facial expression, crying, breathing patterns, and state of arousal for each infant was then calculated. Physiological changes such as heart rate, respiration, and oxygen saturation was collated and analyzed as specified in Appendix B. The time was measured to the nearest minute using a stop watch. All circumcised neonates came for follow-up on the seventh day of the circumcision.
3.9 METHOD OF DATA ANALYSIS
Data analysis was conducted using EPI-INFO version 3.3.Student t-tests were performed comparing the two randomized groups. Mean values for NIPS, heart rate, oxygen saturation, respiratory rate and duration of the circumcision were analyzed separately. A secondary analysis was performed comparing mean values of NIPS, heart rate, oxygen saturation, respiration rate and the duration of circumcision of the neonates who received local anaesthesia with those who did not receive anaesthesia before the circumcision. Significance was assigned if P < 0.05.
3.10 ETHICAL CONSIDERATION
Approval for the study was obtained from the ethical committee of Plateau State Specialist
Hospital, Jos (Appendix D). Informed written consent was obtained from the neonate’s mothers
(Appendix A).
It is the current practice in the study centre to perform neonatal circumcision without anaesthesia. There was therefore no major ethical issue involved in randomizing one group to circumcision without anaesthesia.
65 CHAPTER FOUR: RESULTS.
Seventy-two neonates participated in the study. They were divided into two groups, with thirty-six neonates in each group. Group one (experimental group) were circumcised with local anesthesia. Group two (control group) were circumcised without local anesthesia.
4.1 PHYSICAL CHARACTERISTICS OF THE NEONATES.
All the neonates in the experimental and the control groups studied were comparable with regards to Age, weight, head circumference and length. Table 1 below shows the physical characteristics in the two groups studied.
Table 1: Physical characteristics of the neonates
TREATMENT ALLOCATION CHARACTERISTICS ANAESTHESIA NO ANESTHESIA (N: 36) (N: 36)
AGE (Days) No. % No. % 2-8 5 13.9 4 11.1 9-15 18 50 24 66.7 16-22 7 19.4 4 11.1 23-29 6 16.7 4 11.1
WEIGHT (Kg) 2.5-3.0 6 16.6 10 27.8 3.01-3.50 5 13.9 11 30.5 3.51-4.50 15 41.7 10 27.8 >4.50 10 27.8 5 13.9
HEAD CIRCUMFERENCE (cm) 30-35 8 22.2 10 27.8 36-40 27 75 26 72.2 >40 1 2.8 0 0
LENGTH (cm) 40-45 0 0 4 11.1 46-50 11 30.5 13 36.1 51-55 20 55.6 17 47.2 56-60 2 5.6 2 5.6 >60 3 8.3 0 0
66
4.2 SOCIO-DEMOGRAPHIC CHARACTERISTICS OF THE PARENTS.
Table 2 below shows the socio-demographic characteristics of the parents of neonates in the two groups studied, and was comparable with regard to occupation, education level, religion and marital status.
Table 2: Socio-demographic characteristics of the parents of the neonates
ANAESTHESIA (N: 36) NO ANAESTHESIA (N: 36) CHARACTERISTIC FATHER MOTHER FATHER MOTHER No. % No. % No. % No. %
OCCUPATION Business 12 33.3 9 25 9 25 7 19.4
Civil Servant 17 47.2 9 25 18 50 7 19.4
Skilled Worker 3 8.3 2 5.6 4 11.1 1 2.8
Unemployed 6 11.1 16 44.4 3 8.3 21 58.3
RELIGION Christianity 33 91.4 34 94.4 36 100 36 100 Islam 3 8.6 2 5.6 0 0 0 0 Others 0 0 0 0 0 0 0 0
EDUC. LEVEL Primary 2 5.6 3 8.3 1 2.8 1 2.8 Secondary 11 30.5 11 31.5 14 38.9 15 41.6 Tertiary 23 63.9 20 57.4 21 58.3 20 55.6 None 0 0 1 2.8 0 0 0 0
MARITAL STATUS Married 35 97.2 33 91.7 Single 1 2.8 3 8.3 Divorced/Separated 0 0 0 0 Widow 0 0 0 0
ETHNICITY Berom 3 8.3 7 19.4 3 8.3 3 8.3 Idoma 4 11.1 3 8.3 0 0 2 5.6 Mwaghavul 6 16.7 6 16.7 2 5.6 3 8.3 Others 23 63.9 20 55.6 31 86.1 28 77.8
67 4.3 NEONATAL INFANT PAIN SCORES.
The neonatal pain scores during the surgery are shown in Table 3 below.
Table 3: Neonatal pain scores during the surgery
S.N NEONATAL PAIN SCORES DURING CIRCUMCISION
ANAESTHESIA NO ANAESTHESIA
Facial cr Breathi Arm State Facial cr Breathi Arm State expressi y ng movem of expressi y ng movem of on pattern ent arous on pattern ent arous al al 1. 1 1 1 1 1 1 2 1 1 1
2. 1 0 1 0 1 1 2 1 1 1
3. 1 1 1 1 1 1 2 1 1 1
4. 1 1 1 1 1 1 2 1 1 1
5. 1 1 1 1 1 1 2 1 1 1
6. 1 1 1 1 1 1 2 1 1 1
7. 1 1 1 1 1 1 2 1 1 1
8. 1 1 1 1 1 1 2 1 1 1
9. 1 1 1 1 1 1 2 1 1 1
10. 1 1 1 1 1 1 2 1 1 1
11. 1 1 1 1 1 1 2 1 1 1
12. 1 1 1 1 1 1 2 1 1 1
13. 1 1 1 1 1 1 2 1 1 1
14. 1 1 1 1 1 1 2 1 1 1
15. 1 1 1 1 1 1 2 1 1 1
16. 1 1 1 1 1 1 2 1 1 1
17. 1 1 1 1 1 1 2 1 1 1
68 18. 1 1 1 1 1 1 2 1 1 1
19. 1 1 1 1 1 1 2 1 1 1
20 1 1 1 1 1 1 2 1 1 1
21 1 1 1 1 1 1 2 1 1 1
22 1 1 1 1 1 1 2 1 1 1
23 1 1 1 1 1 1 2 1 1 1
24 1 1 1 1 1 1 2 1 1 1
25 1 1 1 1 1 1 2 1 1 1
26 1 1 1 1 1 1 2 1 1 1
27 1 1 1 1 1 1 2 1 1 1
28 1 1 1 1 1 1 2 1 1 1
29. 1 1 1 1 1 1 2 1 1 1
30 1 1 1 1 1 1 2 1 1 1
31 1 1 1 1 1 1 2 1 1 1
32 1 1 1 1 1 1 2 1 1 1
33 1 1 1 1 1 1 2 1 1 1
34 1 1 1 1 1 1 2 1 1 1
35 1 1 1 1 1 1 2 1 1 1
36. 1 1 1 1 1 1 2 1 1 1
Tot 36 3 36 35 36 36 7 36 36 36 5 2 al
69 Table 4: Mean pain Scores (NIPS) during surgery
TREATMENT ALLOCATION.
PARAMETERS
ANAESTHESIA NO ANAESTHESIA
Facial expression 36 36
Cry 35 72
Breathing Pattern 36 36
Arms movement 35 36
State of Arousal 36 36
TOTAL 178 216
The above pain scores were recorded during lateral clamping of the skin, lyses of adhesions, dorsal cutting, retraction for further lyses of adhesions, tying of the surgical knot and removal of excess skin. The mean scores were taken for each of the study groups mentioned above. Those circumcised with local anaesthesia had significantly lower means NIPS compared to those circumcised without local anaesthesia.
70
71
72 4.4 COMPARISON OF MEAN NEONATAL INFANT PAIN SCORES.
The mean NIPS scores were lower in those circumcised with local anaesthesia compared with those circumcised without local anaesthesia (4.96+/-0.23 VS 6.00+/-0.00) at p< 0.05 as shown in
Figure 1 below.
FIG 1: COMPARISON OF MEAN PAIN SCORES (NIPS)
The higher NIPS scores in neonates circumcised without local anaesthesia indicated severe pain. Overall, the neonates that did not receive local anaesthesia demonstrated a greater pain response than did the neonates circumcised using local anaesthesia. All neonates who were circumcised without anaesthesia had the maximum NIPS score of six throughout the entire procedure. There was variation in NIPS scores as a function of the stage of the circumcision that was being performed for both groups. In both groups, NIPS scores were higher during lysis of adhesion and tying of the plastibell than during clamping, dorsal incision, or cutting of the foreskin. Nevertheless, in all the events that took place during the circumcision, NIPS scores were significantly lower in the group that received local anaesthesia compared to the group that had no local anaesthesia as shown in Fig 1 above.
73 Table 5: Physiological changes due to pain in the neonates during circumcision
4.5 PHYSIOLOGICAL CHANGES DURING CIRUMCISION.
Treatment allocation P Value
Parameters Anaesthesia No anaesthesia
Mean+/-SD Mean+/-SD
Heart rate 133.86+/35.00 152.11+/-79.80 < 0.0001
Respiratory rate 49.69+/-2.9 51.52+/-6.77 < 0.0001
Oxygen saturation 90.47+/-7.53 85.83+/-5.61 < 0.0860
The physiological changes due to pain during the circumcision included heart rate, respiratory rate, and oxygen saturation. These are presented in Table 5 below.
4.5.1 HEART RATE
Throughout the circumcision, the unanaesthetized group demonstrated marked increases in heart rate. The group given local anaesthesia had smaller increases in heart rate compared with the unanaesthetized group during circumcision (p<0.0001) as shown in Table 4 above.
The mean heart rate was increased for those circumcised without local anaesthesia compared to those circumcised with local anaesthesia (mean 152.11+/-79.80 vs. 133.86+/-35.00) as shown in
Table 4 above indicating that the use of local anaesthesia was associated with less increase in heart rate than without local anaesthesia.
A significant difference in the heart rates between groups was observed during the dissection and following the application of the circumcision plastibell clamp. Both groups demonstrated heart rates higher than base line while resting undisturbed toward the end of the procedure. The entrapping of the infant from the circumcision operation table produced an elevation in heart rate
74 in both groups. Handling of the penis produced a statistically significant elevation in heart rate in the unanaesthetized group compared with heart rate of the anaesthetized group (P <0 .05). The heart rate of both groups had returned to near preoperative base line values by the end of one hour postoperative monitoring period. In both groups, heart rates were higher during lysis of adhesion and tying of the plastibell than during clamping, dorsal incision, or cutting of the foreskin.
4.5.2 RESPIRATORY RATE
The mean respiratory rate was increased in those circumcised without local anesthesia compared with those circumcised with local anesthesia (51.52±6.77 vs. 49.69±2.95) as shown in table 5 above. Respiratory rates did not differ significantly between groups at any time during the study. Although respiratory patterns varied with periods of crying, characterized by a slower respiratory rate, and subsequent hyperventilation, the mean respiratory rates between groups did not reflect specific pattern changes.
4.5.3 OXYGEN SATURATION
Oxygen saturation dropped progressively in those without local anaesthesia, as they were being circumcised. Crying and increased intra-thoracic pressure is believed to have caused the desaturation. The local-anesthesia group, maintained oxygen saturation at a steady level compared with those without local anaesthesia group during the circumcision.
The mean oxygen saturation decreased among those circumcised without local anesthesia compared to those circumcised with local anesthesia (85.83±5.61% vs. 90.47±7.53%).The difference in the oxygen saturation in the two groups was not statistically significant. The transcutaneous Po2 for both groups decreased when the neonates were strapped onto the circumcision operation table and during the antiseptic scrub. Injection of the lidocaine in the anaesthetized group delayed the time for return of the transcutaneous Po2 toward the baseline,
75 compared with the almost immediate post handling recovery for the neonates who did not receive injections.
Usually a decrease in transcutaneous Po2 level is followed by a rebound above base line level.
Both groups of neonates in this study displayed this response. After dissection of the prepuce- glans plane began, the anesthetized group demonstrated a drop of transcutaneous Po2 from the elevated transcutaneous Po2 rebound level back toward the base line. The unanaesthetized group had a lower value above the base line transcutaneous Po2 during the dissection period.
The transcutaneous Po2 values of both groups rebounded after tying of the surgical knot around the plastibell groove and remained above the base line levels until the neonate was cleaned. In both groups, oxygen saturation was lower during lysis of adhesion and tying of the plastibell than during clamping, dorsal incision, or cutting of the foreskin.
4.6 DURATION OF CIRCUMCISION
There was no significant difference between circumcision time for those circumcised with local anesthesia and those circumcised without local anesthesia. The mean duration of surgery
(minutes) was 7.16±1.57 for Anaesthesia group and 7.69±1.92 minutes for without anaesthesia group as shown in Figure 2 below
76 Fig 2: COMPARISON OF MEAN DURATION OF SURGERY IN MINUTES
4.7 COMPLICATIONS OF NEONATAL CIRCUMCISION
About seven of those that had local Anaesthesia bled while those that had No anaesthesia had no complication as shown in figure 3 below.
77 FIG 3: COMPLICATIONS OF NEONATAL CIRCUMCISION
78 4.8 REASONS FOR CIRCUMCISION.
Various reasons were given for the circumcision, 59.7% of neonates’ mothers responded that they want their children to be complete men as their Father. And 12.5% of the neonates’ mothers said it was commanded in the Holy Books of both the Bible and the Quran for a male child to be circumcised. For traditional reasons 25% of neonates’ mothers responded that it was a tradition for a male child in their community to be circumcised. Also 2.8% of the neonates’ mothers gave no reasons at all for the circumcision of their children as shown in figure 4 below.
FIGURE 4: REASONS FOR CIRCUMCISION
79 CHAPTER FIVE: DISCUSSION
Circumcision is the commonest procedure performed in the neonatal population.4 There is belief that neonates do not experience pain with the same intensity as adults.11 Physicians still may be reluctant to use anaesthesia for circumcision of neonates because of concern regarding efficacy and safety. Circumcision is a frequently performed neonatal procedure that is often done without the benefit of anaesthesia. No study has described the benefits of local anaesthesia for neonatal circumcision in our environment. This study hypothesized that if local anaesthesia could demonstrate the efficacy in providing pain relief, then more family physicians would use local anaesthesia when performing circumcisions. This study evaluated pain in neonates during circumcision with local anaesthesia.
5.1 PHYSICAL CHARACTERISTICS OF NEONATES
The common age for neonatal circumcision is 2 to 30 days.92, 97 In a study done by Taddio et al in United States of America, the physical characteristics did not differ between the two groups studied that is, the anaesthesia and non anaesthesia groups.92 The mean age and weight for the two groups were 17+/- 2 days in that study and birth weight was 3.2+/-0.68 kg. In this study all the neonates in the experimental and the control groups studied were comparable with regards to the physical characteristics. The mean age and birth weight for the groups were age 13+/-7 days and 3.66+/-0.51kg. Also the head circumference was 36.34+/-2 cm, and length 51.3 +/-3.6 cm at circumcision for those who had local anaesthesia and those who had no local anaesthesia.
Though the other study was done in the United States of America, the similarity between the two studies is that, the circumcision was performed on neonates and the neonates exhibit similarity in physical characteristics. The differences in birth weights could be that the mothers in the study of
Taddio et al are more affluent than their counterparts in this part of the country. The head circumference and the lengths of the neonates were not included in the study by Taddio et al’s.
80
5.2 SOCIO-DEMOGRAPHIC CHARACTERISTICS OF THE PARENTS.
Circumcision has been proposed as a means of marking those of lower or higher social status different from non-circumcising neighbors.106 In this study the socio-demographic characteristics of the parents of the neonates in the two groups studied were comparable with regards to occupation, education, religion, ethnicity and marital status.
Newborns undergo circumcision because parental decision making is based on social or socioeconomic concerns about attitudes of peers and their sons’ self concept in the future.65
Circumcision became a class marker of those wealthy enough to afford a hospital birth.106 In this study the upper class consisted of businessmen and the civil servants and the middle class consisted of skilled workers. The majority of the neonates circumcised in this study belonged to the upper and middle classes. The neonates that belonged to the unemployed were few compared to the above two classes. It follows that social or socioeconomic classification still exist today in terms of accessibility and utilization of orthodox health services by the upper and middle classes; and only few in the poor class can afford circumcision of their neonates in the hospital. The hospital charges range from three to five thousand naira in the study centre. The poor class probably utilizes alternative ways of circumcising their children by traditional methods of circumcision.
Circumcision is a religious practice required by both Christianity and Islam.107 This study is in conformity with the religious practice of both Christianity and Islam.
A study by Waldeck in Cincinnati Ohio in the United States of America found that educated parents almost always had their newborn sons circumcised while the infant sons of uneducated
81 and poor parents were usually uncircumcised because their parents were unaware of the benefits and could not afford the cost.106 The neonates in this study were from Jos metropolis and its surrounding villages. This study demonstrated that the educated parents still maintained the lead as in other studies; as the majority of neonates whose parents attended tertiary education were circumcised. The parents are better informed and can afford the cost of circumcision.
The author did not come across any study about the marital status of the neonates’ mothers, in this study, the finding is a reflection of the societal norms, where single parenthood is frowned upon and child-bearing is expected to be within the context of marital relationships.
Jos weather is cool all year round and it is endowed with beautiful landscapes which attract various Nigerian ethnicities to settle in the city. The practice of circumcision is therefore not unique to any particular ethnic group.
5.3 NEONATAL INFANT PAIN SCORES
Several studies have addressed pain reducing interventions during circumcision.77,78,79 Taddio et al demonstrated that anaesthesia decreases the pain of circumcision.84 In another study, it was demonstrated that local anaesthesia was extremely effective in reducing the pain of circumcision as indicated by a low mean NIPS score at forceps application, dorsal incision, application of clamp and foreskin cutting. In contrast, the unanaesthetized neonates demonstrated marked increase in NIPS score during all phases of the circumcision.92 The results indicated that local anaesthesia usage during circumcision is associated with an average NIPS score of 4.8 and 6.0 in those without anaesthesia.92 Razmus et al reported that newborns circumcised with dorsal nerve block and ring block (local anaesthesia) had the lowest NIPS scores.113
82 In this study, the NIPS score were recorded during lateral clamping of the skin, lyses of adhesions, dorsal cutting, retraction for further lyses of adhesions, tying of the surgical knot and removal of excess skin. The mean scores were taken for each of the studied groups. The NIPS scores were lower in those circumcised with local anaesthesia compared to those circumcised without local anaesthesia. The neonates that were circumcised without local anaesthesia demonstrated marked pain scores (NIPS). The local anaesthesia modified these changes. The usage of local anaesthesia during circumcision was associated with an average NIPS score of
4.96. In this study the NIPS scores were similar to scores found in a study done by Taddio et al; local anaesthesia is better than dorsal nerve block.47,92 There was no doubt that neonatal circumcision produced severe and persistent pain.
Several studies in neonates have addressed pain-reducing interventions during circumcision including use of pacifiers, swaddling, and medication.49,59,60,61 It is important to remember, however that none of these have been proven to be effective as local anaesthesia, and at the present time should be considered for use in addition to, and not in place of local anaesthesia.
Several studies68, 91, 92, including the present one confirm that local anaesthesia is an effective method of reducing pain during circumcision. It is clear that local anaesthesia reduces pain significantly during anaesthesia. There is also evidence that unanaesthetized neonatal circumcision is associated with an increased pain response to vaccination at four to six months of age.79
This study has shown that the pain of circumcision can be minimized or eliminated by use of local anaesthesia. The least painful circumcisions were performed with local anaesthesia, as more than half of all neonates circumcised with this method did not cry at all. The performance of
83 circumcisions without anaesthesia should no longer be condoned or considered acceptable in clinical setting.
It is likely that the popularity of circumcision will increase based on prevailing medical opinions as to its benefits. It is also likely that despite changing trends it will continue to be performed on a significant percentage of neonates. It is therefore imperative that if it is going to be performed, it should be performed in a manner that causes the neonate as little pain as possible.
5.4 PHYSIOLOGICAL AND BEHAVIOURAL CHARACTERISTICS
A study by Taddio showed that infants are affected by the pain of circumcision.91 It found clinical and biochemical evidence that indicates newborn infants exhibit Physiological, autonomic, and behavioural responses to noxious stimuli. Acute responses of neonates to pain stimuli include large increases in heart rate, decreased transcutaneous Po2, and behavioural changes in those who were not anaesthetized.85 The use of local anaesthesia effectively reduces the physiological and behavioural indicators to pain caused by circumcision.85 Results of several double blind, placebo-controlled studies confirm that local anaesthesia decreases excursion from baseline values for tissue oxygenation, heart rate and behavioural changes during circumcision.59,61,64,80
In this study, the physiological variables showed indications of when effective blocking of pain may have been achieved. These mean values were as follows: Transcutaneous Po2 for those that had anaesthesia was 90.47±7.53 compared to 85.83 ± 5.61 in those who had no anaesthesia. The mean heart rate for those that had local anaesthesia was 133.88 ± 35.00 beats per minute compared to 152.11 ± 79.80 beats per minute in those who had no anaesthesia. This result had similar values with other studies done previously by Smithy 88, Sharek89, and Taddio92.
Respiratory rate in neonates is typically reported to increase with pain.89 In this study neonates circumcised without local anaesthesia had higher respiratory rate compared to those circumcised
84 with local anaesthesia. The neonates began to cry at the onset of a painful stimulus and they started breathing more quickly. The mean respiratory rate decreased in those given local anaesthesia compared to those that were not given anaesthesia though it was not statistically significant.
The neonates that were circumcised without local anaesthesia demonstrated marked physiological responses to circumcision. The local anaesthesia modified these changes.
Those who received no local anaesthesia cried loudly and vigorously, trembled, tightened facial muscles and breathing faster. Local anaesthesia significantly decreases pain during circumcision as evidenced by decreasing physiological and behavioral distress associated with the procedure.
The most obvious observation was that the non anaesthetized neonates cried virtually throughout the entire period of the circumcision.
This study demonstrated that local anaesthesia was extremely effective in reducing the physiological variables of circumcision as indicated by a mean heart rate of 133.86 ± 35.00 compared to 152.11+/-79.80, respiratory rate of 49.69+/-2.9 to 51.52+/-6.77 and oxygen saturation of 90.47+/-7.53 to 85.83+/-5.61. The local anaesthesia was more effective in reducing behavioural manifestations of pain at all phases of the circumcision compared with no anaesthesia. The physiological changes reported here show that newborns are responsive to pain. The physiological changes in themselves are probably not detrimental to the well-being of healthy term neonates. However, they do indicate pain by stress-directional changes in objective measures that do not occur in anesthetized neonates.
85 With these findings, it is hoped that the tradition of performing neonatal circumcision without the benefit of anaesthesia will no longer continue.
5.5 COMPLICATIONS OF NEONATAL CIRCUMCISION
Circumcision is a surgical procedure. While the risk of complications in a competently performed circumcision is very low, complications resulting from circumcision include postoperative bleeding, and infection which can be catastrophic.18
According to American Medical Association, blood loss and infection are the most common complications, although bleeding is mostly minor and haemostasis can be achieved by pressure application.10 The complication rates according to some studies vary from 0.1% to 35%.18,19,21 A
2004 Cochrane review which compared dorsal penile nerve block and local anaesthesia found both anaesthetics appear safe.110
In this study the only complication that was encountered was bleeding. Bleeding occurred in
19.4% of those who had anaesthesia while none was observed in those that had no anaesthesia.
It was speculated that the bleeding might have been caused by injection of the local anaesthesia which might have ruptured some blood vessels.. This complication rate fell within the limit of
0.1% to 35% quoted by previous studies.18, 19, 21
A physical examination was also performed one hour after circumcision. No short-term complications were observed during the course of this study. Studies assessing the short-term behavioral changes produced in newborns circumcised without anaesthesia have revealed sleep disturbances.79
86 A controlled blind study using the Brazelton Neonatal Behavioral Assessment Scale showed that
90% of the infants changed behavior categories after being circumcised without an anesthetic, when examined after surgery.80
Some long-term behavioral consequences of unanaesthetized newborn circumcision were suggested by studies of neonate gender differentiation. 68 Short- and long-term behavioral and physiological effectiveness and side effects of using a local anesthetic in newborns merit further evaluation.
5.6 DURATION OF SURGERY
In this study, the mean procedure time with local anaesthesia was 7.69±1.92 minutes compared to no anaesthesia which was 7.16±1.57 minutes. Other studies using local anaesthesia compared to no anaesthesia reported a procedure time ranging from five to fifteen minutes.68 The time difference between the two groups was due to the distortion of the normal anatomy of the tissues by the injection of lidocaine which was difficult to find the groove of the plastibell to tie the knot of the string. The time difference in this study was not statistically significant at p < 0.05.
5.7 REASONS FOR NEONATAL CIRCUMCISION
Circumcision is performed for religious, aesthetic, cultural or ceremonial purposes, medical reasons or as a form of body modification. In this study various reasons were given for the circumcision.
The majority of mothers responded that they want their sons to “look like dad.” This response is similar to previous studies done in Nigeria109 and by Joseph in Albany, New York in the United
States of America.114
Circumcision is a religious practice amongst Christians, Muslims, some traditions and cultures.108
Adherence to religion, tradition, custom and cultural expectations were some of the reasons for
87 circumcision.110 In this study, it was reflected by mothers who responded that it was a tradition and religious rite for a male child in their community to be circumcised. This finding was similar to studies done previously in Africa110, Asia111 and Europe.112 In some societies circumcision has become medicalised and is simply performed in infancy without any particular conscious religious or cultural significance.7 This is not surprising some mothers to give no reason because circumcision has been seen as part of hospital procedure for hospital deliveries.
5.8 IMPLICATIONS FOR FAMILY PHYSICIANS
This study has implications for other procedures performed on neonates, such as chest tube insertions and lumbar punctures. Sick and premature neonates may be at risk for even more deleterious effects than physiological stress response measured here in healthy, full-term neonates.
The drastic rise in heart rate and the increase in respiratory rate seen in the unanaesthetized subjects during circumcision raised questions about the danger of severe pain. While the physiologic changes did return to normal after surgery, they not only indicate a pain response but they also verify an increase in body metabolism and accelerated glucose consumption. Thus increased energy expenditure during circumcision without anaesthesia could lay the groundwork for problems with hypoglycemia, something newborns are particularly susceptible to. The use of local anaesthesia during circumcision is especially important because of the risks associated with prolonged pain, severe physiologic stress, and hypoglycemia.
The pain associated with chest tube insertion, lumbar puncture, insertion of percutaneous central lines and other procedures commonly performed on high risk neonates may be significantly reduced with use of an appropriate local anaesthesia block technique.
88 5.9 CONCLUSION
The NIPS scores, transcutaneous oxygen levels, heart rate, and respiratory rate were monitored before and during circumcision. Newborns receiving the 1% lidocaine (Xylocaine) subcutaneous injection experienced significantly less stress, as evidenced by smaller decreases in transcutaneous oxygen levels, less time spent crying, and smaller increases in heart rate, than infants circumcised without an anesthetic.
The physiologic pain-stress response of well, normal, full-term male newborns to unanaesthetized circumcision is significantly different from the response of infants circumcised under local anaesthesia.
Whenever the use of local anaesthesia is as simple as infiltrating lidocaine subcutaneously, adds little time or risk to the primary procedure, and is not otherwise contraindicated, it should be considered for its effectiveness in reducing the physiologic pain-stress response of newborns.
This data indicate that local anaesthesia provides better pain reduction during neonatal circumcision. Neonates in this study who received local anaesthesia had lower NIPS scores and a significantly lesser rise in heart rate over the duration of the circumcision compared with neonates who received no anaesthesia.
Therefore the investigator endorses the use of local anaesthesia for neonatal circumcision.
Unless another method is proven to be as effective, local anaesthesia should be used for all circumcisions. Other ancillary methods of circumcision pain control continue to be investigated.
They include dipping pacifiers in sucrose solution, various forms of swaddling, topical anaesthestics, and others. The effectiveness of local anaesthesia in reducing the stress of
89 neonatal circumcision was evaluated by monitoring several physiological variables in healthy full- term newborns.
Inasmuch as local anaesthesia presents no additional risk, is simple to learn, adds little time or expense to the overall procedure, and appears to reduce the physiologic stress, it should be utilized for every newborn undergoing circumcision so long as it is not otherwise contraindicated.
5.10 RECOMMENTATION.
This study indicates that local anaesthesia provides pain reduction during circumcision.
Therefore local anaesthesia is recommended for neonatal circumcision.
5.11 CONSTRAINT.
1. Paucity of local literature about neonatal circumcision with or without Anaesthesia.
2. The study therefore relied on work done in centers outside Africa.
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101 APPENDIX A: CONSENT FORM.
Dear Parents.
I’m, Dr. Aminu Fikin, a resident Doctor in Family Medicine Department of Plateau State Specialist
Hospital, Jos, conducting a study to assess pain with or without aneasthesia during neonatal circumcision using the Neonatal infant pain scale [NIPS].The infants will be randomized to circumcision either with or without anaesthesia. If you agree to participate in this study, I will carry out the following:-
1. Ask questions about the demographic data of the child.
2. Perform clinical examination including the weighing of the child.
3. Perform the circumcision by using clamps or a plastibell device.
4. Any information given will be treated as confidential even after the study has ended.
5. The surgery will cause some pains to your child but I will be gentle as possible.
Participation in the study will not add to the cost of treatment of your child.
Your child’s participation is voluntary and you reserve the right to decline. Withdrawal will not affect your child’s treatment. However, I solicit your co-operation to enable me obtain meaningful results. All information collected for this study will be kept confidential.
Do you have any questions about the study?
102 I willingly agree for my child to participate in this study.
Study No. of the Baby ______
Signature or Thumbprint of father/mother ______
Name/ Signature of the witness/Date ______
103 APPENDIX B: QUESTIONNAIRE
A. General Data.
1. Study No.______2. Hosp. No.______3.Date______
4. Age ______5. Informant______6. Reason for the circumcision______
B. Socio-demographic characteristics of the parents.
1. Occupation of:
a) Father ______
b) Mother______
2. Religion of:
a) Father______
b) Mother______
3. Ethnicity of:
a) Father______
b) Mother______
4. Educational level of:
104 a) Father______
b) Mother______
5. Marital status of the mother
a) Married: ______
b) Single: ______
c) Divorced/Separated: ______
d) Widow: ______
C. Physical examination.
1. Heart rate______
2. Respiratory rate______
3. Breathing pattern______
4. Oxygen saturation______
105
5. Length [cm] ______Head circumference [cm] ______
6. Weight______
8. Duration______
D. COMPLICATIONS.
a).Immediate (from the time of surgery to one hour after the surgery) __ b).Late
______
106 APPENDIX C: NEONATAL/INFANT PAIN SCALE (NIPS)
Neonatal/Infant Pain Scale (NIPS) 17 (Modified)
(Recommended for children less than 1 year old) - A score greater than 3 indicates pain.
Pain Assessment Score Facial Expression 0 – Relaxed muscles Restful face, neutral expression 1 – Grimace Tight facial muscles; furrowed brow, chin, jaw, (negative facial expression – nose, mouth and brow) Cry 0 – No Cry Quiet, not crying 1 – Whimper Mild moaning, intermittent 2 – Vigorous Cry Loud scream; rising, shrill, continuous (Note: Silent cry may be scored if baby is intubated as evidenced by obvious mouth and facial movement. Breathing Patterns 0 – Relaxed Usual pattern for this infant 1 – Change in In drawing, irregular, faster than usual; gagging; breath Breathing holding Arms 0 – No muscular rigidity; occasional random movements of arms Relaxed/Restrained 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion Legs 0 – No muscular rigidity; occasional random leg movement Relaxed/Restrained 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion State of Arousal 0 – Sleeping/Awake Quiet, peaceful sleeping or alert random leg movement 1 – Fussy Alert, restless, and thrashing
N.B. Legs movement will be excluded because the infant will be restrained on theatre bed
107 APPENDIX D: ETHICAL CLEARANCE
108 APPENDIX E: CIRCUMCISION INSTRUMENTS
109