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: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 220

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 60 to 80 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: 222
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 self-administering the study drug using the PENTHROX® inhaler.
5. Treatment with any analgesic agent within 5 hours prior to presentation to ED, except Entonox (50% nitrous oxide and 50% oxygen mixture) which is prohibited within 30 minutes prior to arrival at ED, diclofenac which is prohibited within 8 hours prior to presentation to ED or oral morphine which is prohibited within 10 hours prior to presentation to ED.
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.Known significant cardiovascular disease (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
Main Objective: To evaluate the efficacy of PENTHROX® (methoxyflurane) for the treatment of acute pain in paediatric patients presenting to an Emergency Department (ED) with minor trauma;Secondary Objective: To evaluate the safety of PENTHROX® (methoxyflurane) for the treatment of acute pain in paediatric patients presenting to an ED with minor trauma.;Primary end point(s): •Difference in pain intensity between active drug and placebo as measured by VAS from baseline to 15 minutes after the commencement of treatment;Timepoint(s) of evaluation of this end point: 15 minutes after commencement of treatment

Secondary Outcome Measures

Name	Time	Method

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