Objective: The purpose of this work was to evaluate the analgesic properties of oral sucrose during routine immunizations in infants at 2 and 4 months of age.
Patients and methods: A prospective, randomized, placebo-controlled clinical trial was conducted at a pediatric ambulatory care clinic. One-hundred healthy term infants scheduled to receive routine immunizations were recruited, randomly stratified into 2- or 4-month study groups, and further randomly assigned to receive 24% oral sucrose and pacifier or the sterile water control solution. The study preparations were administered 2 minutes before the combined diphtheria-tetanus-acellular pertussis, inactivated polio vaccine, and hepatitis B vaccine. Haemophilus influenzae type b vaccine was administered 3 minutes after the combined injection, followed by the pneumococcal conjugate vaccine, 2 minutes after the H. influenzae type b injection. The University of Wisconsin Children's Hospital Pain Scale measured serial acute pain responses for the treatment and control groups at baseline and 2, 5, 7, and 9 minutes after solution administration. Repeated-measures analysis of variance examined between-group differences and within-subject variability of treatment effect on overall pain scores.
Results: Two- and 4-month-old infants receiving oral sucrose (n = 38) displayed reductions in pain scores 2 minutes after solution administration compared with 2- and 4-month-old infants in the placebo group (n = 45). Between-group comparisons for the oral sucrose and placebo groups showed lower pain responses at 5, 7, and 9 minutes after solution administration. The oral sucrose and placebo groups demonstrated their highest mean pain score at 7 minutes, with a mean pain score of 3.8 and 4.8, respectively. At 9 minutes, the placebo group had a mean pain score of 2.91 whereas the mean pain score for the oral sucrose group returned to near baseline, reflecting a 78.5% difference in mean pain score (oral sucrose - placebo) relative to the placebo mean.
Conclusions: Oral sucrose is an effective, easy-to-administer, short-acting analgesic for use during routine immunizations.
Trial registration: ClinicalTrials.gov NCT00150189.