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#164 Double-blind randomised placebo-controlled study of paediatric acute trauma pain treatment with methoxyflurane
  1. Stuart Hartshorn1,
  2. Michael J Barrett2,
  3. Ben Bloom3,
  4. Mark D Lyttle4,
  5. Emily Walton5,
  6. Kim Steel6,
  7. Sue Anne Yee7,
  8. Alan T Irvine8,
  9. In association with PERUKI9
  1. 1Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, UK; Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  2. 2Department of Emergency Medicine, Children’s Health Ireland at Crumlin, Dublin, Ireland; Women’s and Children’s Health, School of Medicine, University College Dublin, Dublin, Ireland
  3. 3Emergency Department, Royal London Hospital, Barts Health NHS Trust, London, UK; Blizard Institute, Queen Mary University of London, UK
  4. 4Emergency Department, Bristol Royal Hospital for Children, Bristol, UK; Research in Emergency Care Avon Collaborative Hub (REACH), University of the West of England, Bristol, UK
  5. 5Emergency Department, Royal Alexandra Children’s Hospital, Brighton, UK
  6. 6Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Consultant, Medical Developments International
  7. 7Medical Developments International
  8. 8Consultant, Medical Developments International
  9. 9Paediatric Emergency Medicine, UK and Ireland

Abstract

Background Methoxyflurane [MF; PENTHROX®] is a rapidly acting, self-administered non-narcotic analgesic. This study assessed 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 (sodium chloride 0.9% 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 (standard deviation [SD]) age was 11.1 (2.5) years, 17% 6-8 years, 42% 9-<12 years, 41% 12-<18 years; male 56% and white 66%. In the subgroup, mean (SD) age was 11.8 (1.94) years and baseline pain was MF 71.2 (6.96) mm and P 70.4 (6.88) mm. At 15-min, the mean change from baseline in VAS was MF -20.0mm and P -13.2mm (-6.8mm difference [95% CI -12.5 to -1.2mm], p=0.018) in the subgroup; -7.0mm difference [95% CI -12.5 to -1.5mm], p=0.013 overall. 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 treatment emergent adverse event (TEAE) was dizziness (MF 40%, P 9%). 9 MF participants discontinued due to TEAE, and 1 in the P group.

Conclusions In this placebo controlled pivotal trial, methoxyflurane was proven efficacious for the treatment of acute trauma related pain in children and adolescents, with a safety profile consistent with the adult population.

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