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Methoxyflurane Analgesia for Paediatric Injuries

NCT03215056 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Pain, Acute

Interventions

DRUG

Methoxyflurane

PENTHROX 3mL inhalation vapour, liquid

DRUG

Normal saline

Placebo

Sponsors & Collaborators

  • Pediatric Emergency Research in the UK and Ireland (PERUKI)

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Medical Developments International Limited

    lead INDUSTRY

Principal Investigators

  • Stuart Hartshorn · Birmingham Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215056 on ClinicalTrials.gov