A pilot randomized feasibility clinical trial of intranasal vs. intravenous naloxone in pediatric opioid poisoning.

Abstract

The opioid epidemic also affects children, yet treatment options for opioid poisoning in this population remain underexplored. This study evaluated the feasibility of a randomized trial comparing intranasal (IN) and intravenous (IV) naloxone in young children. An open-label, randomized feasibility pilot trial was conducted at a referral hospital in Tehran from January 2021 to April 2023. Children aged 1-12 years presenting with respiratory depression, loss of consciousness, and miosis were eligible. Participants were randomized 1:1 to receive IV naloxone (0.8mg/2mL) or IN naloxone (1.26mg/0.1mL), in addition to basic first aid. The primary clinical outcome was the time from the decision to administer naloxone to the return of normal respiration. Feasibility outcomes included recruitment and retention rates, protocol adherence, acceptability, and data completeness. Thirty-nine children were randomized (median age 27 months). Twenty-nine had abnormal respiration, and all presented with reduced consciousness. All participants responded to naloxone, though two required an additional IV dose. Excluding an outlier, the median time to IV cannulation was 35s (IQR 26-45). The total time from decision to administration and response was 65s (IQR 49-78) in the IV group versus 24s (IQR 20-53) in the IN group. All participants adhered to the protocol, with > 90% satisfaction reported by parents and healthcare providers. This pilot study demonstrated that intranasal naloxone was feasible, safe, and comparable to intravenous administration for the management of opioid poisoning in young children. IRCT20120629010133N7.