Methoxyflurane Analgesia for Paediatric Injuries

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

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.
• Treatments: Methoxyflurane

Criteria

Inclusion Criteria:

1. Patients aged 6 to less than 18 years.

2. Attending ED following minor trauma.

3. Evidence of signed and dated informed consent/assent document indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study*.

4. Pain scores 55 to 85 mm as measured using VAS or 6 to 8 using Wong-Baker FACES Pain Rating scale.

Exclusion Criteria:

1. Critical, life-or limb-threatening condition requiring immediate management.

2. Open fractures.

3. Patients with any other clinical condition that may, in the opinion of the Investigator, impact the patient's ability to participate in the study, or the study results.

4. Patients deemed not cognitively capable of effectively self-administering the study drug using the PENTHROX® inhaler.

5. Treatment with any analgesic agent within 5 hours prior to randomisation, except Entonox (50% nitrous oxide and 50% oxygen mixture) which is prohibited within 30 minutes prior to randomisation, diclofenac which is prohibited within 8 hours prior to randomisation or oral morphine which is prohibited within 10 hours prior to randomisation.

6. Patients with chronic pain.

7. Patients having received an Investigational Medicinal Product (IMP) in the preceding 3 months.

8. Known pregnancy or breastfeeding females.

9. Personal or familial hypersensitivity to PENTHROX® or any fluorinated anaesthetics.

10. Patients requiring oxygen therapy.

11. Patients with known or genetic susceptibility to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.

12. Clinically evident respiratory depression.

13. Previous use of methoxyflurane (including as an IMP).

14. History of signs of liver damage including after previous PENTHROX® (methoxyflurane) use or halogenated hydrocarbon anaesthesia.

15. Known significant renal impairment.

16. Altered level of consciousness due to any cause including head injury, drugs, or alcohol.

17. Known significant cardiovascular instability (e.g., pathological arrhythmia).

18. Inability to participate in telephonic follow-up on (Day 14 ± 2 days) as per study requirement