Comparing the efficacy of Intranasal Fentanyl along with Paracetamol in reduction of pain to Paracetamol alone in neonates undergoing ROP examination- A randomised controlled trial.

Retinopathy of Prematurity (ROP) screening is crucial for preventing blindness in premature infants. Still, the procedure can cause significant discomfort and pain due to bright lights, mydriatic drops, and physical manipulation of the eyes. This discomfort may lead to adverse clinical conditions, impacting the infants’ health and neurodevelopment. Despite various studies on pain management during ROP screening, effective solutions without significant adverse effects have not been consistently found.

In response, we propose a novel approach combining intranasal fentanyl with oral paracetamol alongside standard care. We hypothesize that this combination will significantly reduce pain during the screening process. While prior research has indicated that intranasal fentanyl is safe and effective, there has been limited investigation into the synergistic effects of combining it with oral paracetamol in this context.

This study aims to evaluate the efficacy and safety of this combined analgesic strategy, addressing a knowledge gap in current neonatal pain management practices. We hypothesize that administering both intranasal fentanyl and oral paracetamol will be more effective in alleviating pain than paracetamol alone during ROP screening.