Purpose: To evaluate the effectiveness and age-related changes in analgesia of oral sucrose as a preprocedural intervention during routine immunizations in infants at 2 and 4 months of age.
Design: A double-blind, randomized, placebo-controlled clinical trial of 40 healthy term infants scheduled to receive routine immunizations from a pediatric ambulatory care clinic during May 2005 to July 2005.
Methods: Infants received 24% oral sucrose solution or the control solution of sterile water 2 minutes before routine immunizations at both their 2- and 4-month, well-child visits. The University of Wisconsin Children's Hospital pain scale was used to measure serial acute behavioral pain responses at baseline, 2, and 5 minutes after administration of the solution. Repeated measures ANOVA was used to examine between-group differences and within-subject variability of the effects of treatment on overall behavioral pain scores.
Findings: Infants receiving oral sucrose (n=20) showed a significant reduction in behavioral pain response 5 minutes after administration compared to those in the placebo group (n=20). At 2 minutes following solution administration, both sucrose and sterile water showed the highest mean pain score (4.54 and 4.39 respectively) indicating a severe amount of pain. At 5 minutes, the sucrose group returned to near normal at 0.27 while the placebo group remained at 3.02 indicating a percentage difference in mean pain scores relative to sterile water pain scores of 90.9. No statistically significant age-related change in behavioral pain response was noted between 2- and 4-month-old infants at 2 minutes and 5 minutes following treatment administration.
Conclusion: Sucrose is an effective preprocedural intervention for decreasing behavioral pain response in infants after immunizations.
Clinical relevance: Efforts to decrease the pain associated with immunizations can promote parental adherence to recommended immunizations schedules, prevent a resurgence of vaccine-preventable diseases and mitigate adverse neurologic outcomes in infants.