Evaluating the Analgesic Efficacy of Oral Glucose in Mitigating Acute Vaccination-Induced Pain in Term Neonates: A Randomized Controlled Clinical Trial
Abstract
Background: Neonates frequently encounter painful stimuli during routine clinical procedures. Among these, vaccination stands out as a prevalent source of distress, necessitating the adoption of safe, accessible, and efficacious analgesic interventions. This study aimed to investigate the analgesic efficacy of oral glucose administration in attenuating pain associated with Hepatitis B vaccination among term neonates.
Methods: This randomized controlled trial was conducted at Shahid Mustafa Hospital, Ilam, Iran, enrolling 90 term neonates scheduled for Hepatitis B vaccination. Participants were randomly allocated into three distinct cohorts: intervention, placebo, and control. Two minutes prior to the immunization, the intervention group received 2 mL of 25% glucose solution, while the placebo group received an equivalent volume of sterile water. The control group received no intervention. Pain severity was evaluated using the Neonatal Infant Pain Scale (NIPS) within a 1–2-minute timeframe following the procedure. To ensure objectivity, all vaccinations were administered by an expert nurse blinded to the group assignments. Statistical analysis was performed using SPSS version 16, utilizing ANOVA and LSD post-hoc tests to compare groups.
Results: Baseline characteristics, including gestational age, anthropometric measurements (weight, height, head circumference), sex, and mode of delivery, were comparable across all groups with no statistically significant differences. While the glucose-treated group exhibited lower pain scores compared to the sterile water group, this difference did not reach statistical significance (p=0.63). However, a significant reduction in pain intensity was observed in both the intervention and sterile water groups when compared to the control group (p<0.001).
Conclusion: The findings indicate that glucose administration is associated with decreased pain responses in neonates undergoing minor medical procedures. Oral sweet solutions represent a practical, safe, and effective non-pharmacological strategy for pain management during routine immunization in newborn infants.
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