A Randomized, Double-Blind Trial of Oral Sucrose Solution and Placebo for Pain Relief in Retinopathy of Prematurity Examination
Nithipun Suksumek MD*, Chaisiri Jumroendararasame MD**, Nattapong Thitiratsanont MD***, Nopparat Sutarapanakit MD****, Santi Punnahitananda MD*****
Affiliation : * Department of Pediatrics, Phramongkutklao College of Medicine, Bangkok, Thailand ** Department of Ophthalmology, Phramongkutklao College of Medicine, Bangkok, Thailand *** Fort Prachaksinlapakom Hospital, Udonthani, Thailand **** Banphaeo Hospital, Samut Sakhon, Thailand ***** Department of Pediatrics, Chulalongkorn University, Bangkok, Thailand
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 decreased 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). Eleven 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.
Keywords : oral sucrose solution, N-PASS (Neonatal Pain, Agitation and Sedation Scale), retinopathy of prematurity (ROP)
