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.
Phase:
Phase 3
Details
Lead Sponsor:
Medical Developments International Limited
Collaborators:
Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI) Pediatric Emergency Research in the UK and Ireland (PERUKI) Quintiles, Inc.