Mansoura Nursing Journal (MNJ) vol.6. No.1 - 2019 THE EFFECTIVENESS OF ORAL SUCROSE IN MANAGING INFANTS' PAIN DURING IMMUNIZATION Gad R F1, Abusaad FE2, Dowling DA3, Bassiouny MR4, Abd El Aziz MA5. 1Faculty of Nursing, Mansoura University 2Faculty of Nursing, Mansoura University 3Frances Payne Bolton School of Nursing, Case Western Reserve University 4Faculty of Medicine, Mansoura University 5Faculty of Nursing, Mansoura University Email of the corresponding author: [email protected] Abstract Treating pain during vaccination should be a part of pediatric primary health care around the world, as untreated pain in children has short and long-term consequences. Few studies of pharmacologic and non-pharmacologic methods of pain relief during immunization have been conducted in low-and-middle-income countries. Finding a cheap and effective pain intervention would improve primary health care. The current study aimed to evaluate the effectiveness of oral sucrose as a method of pain management during immunization among infants through six months of age. A randomized controlled experimental design was used. The study sample included 80 infants distributed into sucrose and control groups. Data were collected in an Egyptian primary health center. Outcome measures, including pain, as measured by the FLACC pain scale, crying time, and heart rate, were measured at three time points (before, during, and after injection). There were statistically significant differences during and after immunization (p<.001) reflecting lower: scores of pain, crying duration, and rising in heart rate for the sucrose group compared to the control group. The study supports the effectiveness of oral sucrose in managing infants' immunization pain and recommends for providing clinical setting with safe resources and education for proper administration of oral sucrose in pain management. Keywords: Immunization, Oral sucrose, pain management 1. Background and Significance Immunization is considered an complication is fear of injections for essential component of primary health care infants and their parents which leads to as a preventive health measure that occurs non or incomplete –adherence to frequently in childhood. Immunization immunization schedules. Negative produces immune-resistance to infectious experiences with injections lead to the diseases and it saves up to 3 million development of needle fears in some children each year (1). Intramuscular children. These consequences are injection is the commonly route used sometimes neglected or inappropriately during immunization. According to the treated in the infant population (5). Egyptian obligatory immunization To ensure infant safety and schedule, most of injections are given prevent long-lasting consequences related during the first 6 months of life (2). to immunization procedures, methods to Research evidence indicates that manage infants’ pain should be provided. Immunization is one of the most painful Interventions for pediatric procedure- procedures in infancy (3,4). This causes related pain in primary care include distress for the infants, parents, and pharmacological and non-pharmacological providers. The most important methods. Concerning pharmacological Gad R F et., al. methods, analgesia is not routinely used infants' pain during Immunization. The for infants under 6 months of age during study addressed the hypothesis of "Oral painful procedures such as immunization, sucrose will decrease the infants' painful heel lance , and venipuncture (6). experience during immunization". Although topical anesthetic [EMLA] such 2. Methods as lidocaine and prilocaine have been 2.1Study design and setting proved to be effective in decreasing A randomized controlled experimental vaccination needle-related pain in various study was conducted in Child Primary studies, it has to be applied for 20 to 60 Health Care Center (Reayt Tefl Awal), minutes before painful procedure located in Mansoura city, Dakahlia according to which commercial Governate, Egypt. preparation is being used. This pre- 2.2Sampling application time is not always available The study population included infants especially in a busy clinical area like aged two, four or six months who were vaccination clinics (7). Other attending the immunization clinic to pharmacological methods like vapocoolant undergo routine immunizations. Healthy sprays and ethyl chloride which not only breastfed infants who came to the clinic provide immediate onset of action and with their mothers are included in the approximately 20 seconds of dermal and sample. Infant exclusion criteria included epidermal anesthetic duration but also infant unable to tolerate oral fluids, or had produce unpleasant anxious cold sensation received paracetamol in the day prior to particularly in children who perceive it as immunization. The sample size was a painful sensation (8). Delayed onset of determined by using a power = .80 and a action, cost, and inconvenience of medium effect size (.5). The total sample Pharmacological methods have resulted in size was 80 infants, 40 infants in each outweighing of non-pharmacological ones group of the two (sucrose & control) regarding acute pain management (9). groups. Non-pharmacological methods 2.3Instruments have been shown to be effective, costless, Two instruments were used in this study. and convenient in reducing procedure- The first is the Demographic related pain. Administration of sweet- Characteristics instrument, which was tasting solutions, mainly sucrose, has developed for the purposes of the study. It been found to have a pain relieving includes the infant’s name, ID number, effect in both term and pre-term gender, age, weight, pre-injection state, newborns(10). Releasing an endogenous time since last feeding, and randomized opioid activated by the sweet taste is the group (A, B, or C). It was developed by mechanism in which oral sucrose reduces the researcher and revised by pediatric pain, (11). There are a large number of nursing experts. studies and evidence demonstrating The FLACC scale was used to measure analgesic effects of sweet solution in pain before, during, and after the neonatal population but, studies with older immunization injection. The FLACC infants especially those who live in Middle scale, developed by (13), measures pain Eastern countries are lacking (12). based on observations in five categories: Examining the use of non- facial expression, position of legs, activity, pharmacological methods for reducing cry, and consolability, scored 0-2 for each. immunization pain is necessary. The aim Total scores range from zero to ten; 0-4 of this study is to evaluate the indicates mild pain, 5-6 indicates moderate effectiveness of oral sucrose in managing 152 THE EFFECTIVENESS OF ORAL SUCROSE IN MANAGING etc… pain, while 7-10 indicates severe pain. crying time in response to injection up to 2 Interrater reliability is high 0.94 (14). minutes then she assessed the FLACC pain Additionally, crying time and heart rate score. changes were measured as indirect After injection, the researcher reassessed measures of pain. The infant’s crying the FLACC pain score while the second duration in response to the needle- related RA counted the infant's heart rate for one procedure was measured in seconds using full minute. the android application stopwatch (G Stop) The timing of the interventions before offered in Google play store (15). Crying injection was based on the determination was measured up to 2 minutes after of a systematic review (16) that found that injection. to be effective sweet solutions used for Procedure. infants beyond the neonatal period needed After the approval of the Research Ethics to be given not more than one minute Committee of Faculty of Nursing, before the painful procedure for Mansoura University, the official sustainability of the analgesic effect. After permission for conducting the study was finishing the study session, the RA gave obtained from Agency of Egyptian the infant the oral polio vaccine to Ministry of Health and health complete the infant’s required administration office in Dakahlia vaccinations. Governate. The research team consisted of 3. Data collection the researcher and three research assistants Data collection was carried out weekly (RA) who were associate degree nurses over 7 weeks in the spring season of 2015. working in the study setting. The number of participants ranged from The first RA determined if the mother met 15-20 every day. Each infant spent 4 to 6 the inclusion criteria and obtained a minutes in the vaccination room. written consent. 4. Statistical analysis Eighty cards marked A or B were arranged Data were analyzed with SPSS version 21. in a small box; where the first RA nurse Discrete data were described using number asked the eligible infant’s mother to and percent. Association between choose a card from the cards box that categorical variables was tested using Chi- indicated the assigned group: sucrose square test. Data of the study were meeting (Group A) or control group (Group B). In the criteria of parametric data using the vaccination room, the second RA Shapiro-Wilk Test of Normality. assisted the mothers to be seated in a chair Continuous variables were presented as and in holding the baby in a right-sided, mean ± SD (standard deviation) and cradled position then she counted the compared with Student t test. All statistical infant's heart rate for one full minute. After tests were done at fixed values the researcher assessed the FLACC pain significance