Efficacy of Single Dose Oral Paracetamol in Reducing Pain During Examination for Retinopathy of Prematurity: A Blinded Randomized Controlled Trial.

OBJECTIVE: To investigate the efficacy of paracetamol in reducing pain during examination for retinopathy of prematurity (ROP) in preterm infants.

METHODS: A total of 114 infants undergoing eye examination for retinopathy of prematurity screening were prospectively randomized. Topical anesthetic (Proparacaine; Alcaine® drop 0.5%) was applied 30 s before the eye examination in all the infants. The infants in the intervention group (Group 1, n = 58) received 15 mg/kg of oral paracetamol, 60 min before the examination. The control group (Group 2, n = 56) received the same volume of sterile water per oral with an opaque syringe. Primary outcome measurement was pain assessed by Premature Infant Pain Profile (PIPP) score. Secondary outcome measurements were tachycardia (>180 bpm)/bradycardia (<100 bpm), desaturations (<85% for >10 s), and crying time.

RESULTS: The groups were similar for gestational age, birthweight or postnatal age at examination. The intervention group had a significantly lower mean PIPP score during eye examination, following insertion of the speculum [Group 1:12 (9-13) vs. Group 2:14 (13-15), p 0.001]. There were no significant differences between the groups with regard to crying time and the number of the patients with tachycardia/bradycardia and desaturation.

CONCLUSIONS: Oral paracetamol modestly reduces pain scores during eye examinations. Further cross-over trials on dose and frequency of paracetamol and combination of pharmacological with non-pharmacological approaches and paracetamol alone as a single agent in significant pain reduction are needed.