Efficacy of expressed breast milk alone or in combination with paracetamol in reducing pain during ROP screening: A randomized controlled trial
Abstract
Introduction: Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we attempted to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. Materials and Methods: A total of 120 preterm neonates were randomized into three groups: (Group A – control group = 40, Group B – breast milk group = 40, and Group C – oral paracetamol + breast milk = 40). Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The video recorder and analyzer were both blinded to the intervention. Results: PIPP scores before the procedure (PIPP 1) in Groups A, B, and C were 4.09 ± 2.44, 3.25 ± 1.71, and 3.45 ± 2.20. Postprocedure PIPP score (PIPP 2) increased to 15.74 ± 2.42 in Group A, 15.44 ± 2.05 in Group B, and 15.83 ± 1.36 in Group C. There was no significant statistical difference in pain scores in the intervention groups (Groups B and C) compared to the control group (Group A), P = 0.724. PIPP scores recorded postprocedure in Groups A, B, and C were, 7.72 ± 3.43, 6.87 ± 3.46,…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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