Methoxyflurane Analgesia for Paediatric Injuries

Summary

This is a randomised, double-blind, multicentre, placebo controlled study to evaluate the safety and efficacy of methoxyflurane (Penthrox®) for the treatment of acute pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma). It is conducted as part of the Paediatric Investigation Plan (PIP) agreed with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA). The study aims to provide evidence under blinded controlled conditions that Penthrox is safe and effective in patients aged 6 to less than 18 years presenting to ED with pain associated with minor trauma.

Timeline

Start

2017-08-14

Primary completion

2022-06-15

Completion

2022-06-15

Publications

• Background Hartshorn S, Barrett MJ, Lyttle MD, Yee SA, Irvine AT; in collaboration with Paediatric Emergency Research in the UK and Ireland (PERUKI). Inhaled methoxyflurane (Penthrox(R)) versus placebo for injury-associated analgesia in children-the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial. Trials. 2019 Jul 4;20(1):393. doi: 10.1186/s13063-019-3511-4.
• Hartshorn S, Barrett MJ, Bloom B, Lyttle MD, Walton E, Steel K, Yee SA, Irvine A; Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI). Treatment of acute trauma-related pain in children and adolescents with methoxyflurane (Penthrox(R)) compared to placebo (MAGPIE): A randomised clinical trial. Injury. 2025 Dec;56(12):112830. doi: 10.1016/j.injury.2025.112830. Epub 2025 Oct 20.

Drugs

Indications

No indication recorded.