A Randomized, Double-Blind Trial of Oral Sucrose Solution and Placebo for Pain Relief in Retinopathy of Prematurity Examination

Abstract

Background: Retinopathy of prematurity (ROP) examination is a painful procedure that has impact on pain sensitivity, leading to chronic pain. Non-pharmacologic approaches for the treatment of pain include oral sucrose solution. Currently, the data regarding pain relief are limited and lack of standard protocol. Objective: To investigate if oral sucrose solution decreases pain and physiological distress during ROP examination. Material and Method: Infants < 32 weeks gestation or birth weight < 1,500 g or selected infants birth weight between 1,500 and 2,000 g or gestational age more than 32 weeks and infants at risk were enrolled. The intervention group received one dose of 0.2 ml of 24% oral sucrose solution compared to control group who received sterile water as a placebo 2 minutes prior to the first ROP examination. Pain was evaluated using a Neonatal Pain, Agitation and Sedation Scale (N-PASS) before and during eye examination. Results: Forty infants were randomized into 2 groups (19 infants in intervention group and 21 infants in control group). N-PASS was found to be significantly lower in intervention group (2 points difference; p=0.02). 11 infants (57.9%) in intervention and 14 infants (66.7%) in control group had tachycardia with significant increased heart rate from baseline. No serious adverse event was observed in both groups. Conclusion: Single dose of 24% oral sucrose solution is effective in pain reduction during ROP examination.