To evaluate the safety and efficacy of methoxyflurane (PENTHROX®) for the treatment of pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 256

Inclusion Criteria

11.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 55-85 mm as measured using VAS or 6 to 8 using Wong
Baker FACES® Pain Rating scale.
Are the trial subjects under 18? yes
Number of subjects for this age range: 256
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 selfadministering
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 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.Clinically evident cardiovascular instability(e.g., pathological arrhythmia).
18.Inability to participate in telephonic follow-up on (Day 14 ± 2 days) as per study requirement.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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