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Effective Analgesia Using Physical Interventions for Infant Immunizations

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Effective Analgesia Using Physical Interventions for Infant Immunizations ARTICLE Effective Analgesia Using Physical Interventions for Infant Immunizations AUTHORS: John W. Harrington, MD,a,b Stacey Logan, MD,a WHAT’S KNOWN ON THIS SUBJECT: Pain during routine infant Courtney Harwell, MD,a Jessica Gardner, MD,a Jessica immunization causes parental anxiety. Oral sucrose solutions are Swingle, BS,a Erin McGuire, MS,a and Rosemarie Santos, MDa effective pain-reduction strategies. Few studies have measured aDepartment of Pediatrics, Eastern Virginia Medical School, a combined strategy of a physical intervention along with sucrose Norfolk, Virginia; and bDepartment of Pediatrics, Section of to decrease the infant’s pain response. General Academic Pediatrics, Children’s Hospital of The King’s Daughters, Norfolk, Virginia WHAT THIS STUDY ADDS: We demonstrate that a physical, KEY WORDS nonpharmacological intervention called the 5 S’s (swaddling, immunizations, vaccines, pain management, infant, analgesia side/stomach position, shushing, swinging, and sucking) provides ABBREVIATIONS significant pain reduction with or without sucrose during routine 5S’s—swaddling, side/stomach position, shushing, swinging, and sucking 2- and 4-month vaccinations. ANOVA—analysis of variance IRB—internal review board This trial has been registered at www.clinicaltrials.gov (identifier NCT01368861). www.pediatrics.org/cgi/doi/10.1542/peds.2011-1607 abstract doi:10.1542/peds.2011-1607 BACKGROUND: To measure the analgesic effectiveness of the 5 S’s Accepted for publication Jan 11, 2012 (swaddling, side/stomach position, shushing, swinging, and sucking) Address correspondence to John W. Harrington, MD, Department of alone and combined with sucrose, during routine immunizations at Pediatrics, Children’s Hospital of The King’s Daughters, 601 Children’s 2 and 4 months. Lane, Norfolk, VA 23507; E-mail: [email protected] METHODS: PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). We conducted a prospective, randomized, placebo-controlled trial with 2- and 4-month-old infants during well-child visits. Patients Copyright © 2012 by the American Academy of Pediatrics were assigned into 4 groups (2 3 2) receiving either 2 mL of water or FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose. 2 mL of 24% oral sucrose and then either standard-of-care comfort ’ FUNDING: No external funding. measures by parents or intervention with the 5 Ss immediately postvaccination. The Modified Riley Pain Score was used to score the infants’ pain at 15-second intervals for 2 minutes, then every 30 seconds up to 5 minutes postvaccination. Repeated-measures analysis of variance examined between group differences and within-subject variability of treatment effect on overall pain scores and length of crying. RESULTS: Two hundred thirty infants were enrolled. Results revealed significantly different mean pain scores between study groups with the exception of the 5S’s and 5S’s with sucrose groups. These 2 groups had lower similar mean scores over time, followed by sucrose alone, then control. The same trend was found with the proportion of chil- dren crying as with the mean pain score outcome measure. CONCLUSIONS: Physical intervention of the 5 S’s (swaddling, side/ stomach position, shushing, swinging, and sucking) provided decreased pain scores on a validated pain scale and decreased crying time among 2- and 4-month-old infants during routine vaccinations. The use of 5S’s did not differ from 5S’sandsucrose.Pediatrics 2012;129:815–822 PEDIATRICS Volume 129, Number 5, May 2012 815 Downloaded from pediatrics.aappublications.org by guest on June 14, 2015 Immunization administration is one of suck, breastfeeding, skin-to-skin, and Statistical Analysis the most common office procedures swaddling.14–19 Two studies report mod- Power Analysis performed on a healthy infant in a erate success at alleviating infant pain The primary outcome variable of pain pediatric practice.1 Although parents when combining 2 nonpharmacologic understand the importance of immu- techniques together: (1) swaddle and score was evaluated by using a total sample of 230 distributed evenly across nizations, the pain and discomfort as- pacifier20 or (2) swaddle and sucrose.21 4 groups. A 1-way analysis of variance sociated with this procedure is the Psychological interventions, in which (ANOVA) has 99% power to detect at the primary reason parents elect not to a parent or nurse distracts the infant .05 level a difference in means of pain perform timely vaccinations.2 Parents with a toy or a parent is coached by scores characterized by a variance of are not the only ones concerned about a health care provider, have also shown means of .19, assuming that the com- causing unwanted pain. Physicians and some promise.22 Taddio et al have advo- mon SD is 0.43. nurses are 6 times less likely to give all cated for health care providers to con- the recommended vaccines at a visit sider combining multiple strategies to Secondary analyses were conducted by x2 if the number of injections is $33 and help mitigate pain and to enlist parental using a .05 level test, yielding 99% physicians have “strong concerns over support when possible.9 Breastfeed- power to detect differences in crying administering 4 or more vaccines at a ing combines several analgesic effects among participants characterized by single visit.”4 (a comforting person [mother], skin- a variance of proportions of 0.024 and to-skin contact, diversion of attention, an average proportion of 0.20. It is clear that clinicians would like to and the sweetness of lactose) as ef- reduce the pain and parental anxiety, fective for procedural pain.23–25 Un- Statistical Methodology during and soon after vaccination; how- fortunately, if the mother is no longer Demographics variables such as age, ever, there is little evidence that the use breastfeeding or if she would rather gender, and race were evaluated for of analgesics such as acetaminophen not breastfeed while the baby receives significant differences between inter- or ibuprofen are effective.5,6 One study immunizations, than alternative anal- vention groups by using x2 analysis. surveyed 140 pediatricians and found gesic techniques are necessary. For remaining demographic variables that .80% used acetaminophen, which such as gestational age and weight at has added sucrose for palatability as an In his book The Happiest Baby on the 26 birth, 1-way ANOVA tests were used to oral analgesic, pre- or postvaccination, Block, Dr Harvey Karp describes the 5 ’ determine if there were significant dif- as a pain-reducing mechanism.7 How- Ss: swaddling, side/stomach position, ferences between intervention groups. ever, a more recent study conducted by shushing, swinging, and sucking and Pyrmula found that acetaminophen explains how these interventions to- To evaluate mean pain across interven- ’ fl use at the time of vaccination signifi- gether trigger an infantscalmingre ex. tion groups over time, a 1-way ANOVA fi cantly reduces antibody levels to sev- The primary objective of our study was was used followed by least signi cant ’ eral of the vaccine antigens.8 In light of to identify if the 5 Ss could be used as difference post hoc comparisons. To this finding, it is prudent to reevaluate a physical intervention to provide anal- evaluate pain scores at each time in- the use of oral antipyretic analgesics gesiatoinfantsreceiving immunizations. terval across intervention groups, re- with sucrose during routine vaccination peated measure general linear modeling METHODS and provide alternative pain-reduction was performed. mechanisms. Nonpharmacologic pain Randomized Controlled Trial To determine significant differences in proportions of children crying at relief may be the best option for infants This was a prospective, randomized, each time interval, x2 analyses were undergoing painful procedures. partially blinded, controlled study de- performed. Recentreviewsoftheliteraturesupport signed to test the effectiveness of a , the use of concentrated sucrose alone physical intervention by using the 5 S’s For all statistical tests, a P value .05 fi as effective analgesia for the immuni- for analgesic pain control, alone and was considered signi cant. zation of infants.9–12 Although topical in conjunction with sucrose analgesia, anesthetics work,13 they are generally after routine immunizations at 2 and Study Sample and Group Randomization not used in a busy practice because of 4 months of age. This study was ap- expense and a prolonged waiting period proved by the Internal Review Board All patients were enrolled from the after application. Additional interven- (IRB) at Eastern Virginia Medical School General Academic Pediatric outpatient tions to reduce pain during proce- and was registered with clinicaltrials. practice located at the Children’sHospital dures in neonates include nonnutritive gov (NCT01368861). of the King’s Daughters in Norfolk, VA. 816 HARRINGTON et al Downloaded from pediatrics.aappublications.org by guest on June 14, 2015 ARTICLE This practice serves a predominantly 3.2mLofwater2minutesbeforeim- with oral (1.5 mL) Rotarix first, followed urban, Medicaid-enrolled, African Amer- munization and physical intervention by3intramuscularinjections(0.5mL)in ican population and has ∼30 000 annual usingthe5S’s by researcher after alternating thighs of hepatitis B vaccine, visits per year. Inclusion criteria included immunization (Physical Group), and Pentacel (combined diphtheria-tetanus- infants with a gestational age between 32 4.
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