Dr. Stuart Hartshorn1,2, Dr. Michael Barrett3,4, Dr. Benjamin Bloom5,6, Dr. Mark Lyttle7,8, Dr. Emily Walton9, Kim Steel2,10, Dr. Sue Anne Yee11, Dr. Alan Irvine10
1Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, UK, 2Institute of Applied Health Research, University of Birmingham, Birmingham, UK, 3Women’s and Children’s Health, School of Medicine, University College Dublin, Dublin, Ireland, 4Children’s Health Ireland at Crumlin, Dublin, Ireland, 5Emergency Department, Royal London Hospital, Barts Health NHS Trust, London, UK, 6Blizard Institute, Queen Mary University of London, London, UK, 7Emergency Department, Bristol Royal Hospital for Children, Bristol, UK, 8Research in Emergency Care Avon Collaborative Hub, University of the West of England, Bristol, UK, 9Emergency Department, Royal Alexandra Children’s Hospital, Brighton, UK, 10Consultant, Medical Developments International, 11Medical Developments International, Melbourne, Australia
Biography:
Dr Sue Anne Yee is the Associate Director, Medical Affairs, Medical Developments International, Australia. She received a medical degree (MBBS) from the University of Melbourne and a Postgraduate Diploma in Public Health from the University of Otago. Her interests include therapeutic development and cost-effective, evidence-based treatments to improve health outcomes.
Abstract:
Background: Methoxyflurane [MF] is a rapidly acting, self-administered non-narcotic analgesic that has been used for >40 years in children. MAGPIE represents the only placebo controlled clinical study with MF in this population. This study assessed the efficacy of MF for treating acute pain in children attending emergency departments (EDs) following traumatic injury.
Methods: Phase III, randomised, double-blind, placebo [P]-controlled study at 11 UK and Ireland EDs. Children aged 6 to <18 years with pain scores of 60-80mm on a 100mm visual analogue scale (VAS) were randomised 1:1 to P (2x5mL) or MF (2x3mL) for up to 10 successive inhalations, with further intermittent inhalations as required. The primary endpoint was a pre-specified subgroup analysis of MF efficacy in the 9-<18 year population.
Results: 4,513 screened, 249 randomised and 192 treated (of 220 planned, MF 92, P 100 overall; 159 in the age 9 to <18 subgroup (MF 76; P 83)). The mean change from baseline in VAS at 15 min (primary endpoint) was MF -20.0mm and P -13.2mm (-6.8mm difference [95% CI -12.5 to -1.2mm], p=0.018). Fewer participants in the MF arm required rescue medication (MF 9.8% vs. P 30.0%). Adverse events were more common in the MF arm (64%) versus P arm (55%). The most common related TEAEs: dizziness (MF 40%, P 9%), euphoric mood (MF 12%, P 0%), dysgeusia (MF 9%, P 1%), cough (MF 8%, P 1%).
Conclusions: In this trial, methoxyflurane was proven efficacious for this patient population, with a safety profile consistent with the adult population.