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)

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) - MAGPIE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004290-41-GB

Enrollment

220

Registered

2017-01-12

Start date

2017-04-11

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pain in paediatric patients MedDRA version: 20.1 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 100000004867

Interventions

Trade Name: PENTHROX Product Name: PENTHROX Pharmaceutical Form: Inhalation vapour INN or Proposed INN: methoxyflurane CAS Number: 76-38-0 Other descriptive name: PENTHROX Concentration unit: ml milli

Eligibility

Sex/Gender

All

Inclusion 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 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): •Responder analysis – number and percentage of responders, who achieve 30% reduction in VAS score compared to baseline, at 15 minutes. •Responder analysis – exploratory: number and percentage of responders who achieve 30% reduction in VAS score compared to baseline at 5, 10 and 20 minutes. •Change in pain intensity as measured using VAS from baseline to 5, 10, 15, 20 and 30 minutes, followed by a 30-minute interval thereafter until the point of ED discharge/in-patient admission decision. •Rescue medication requested within 20 minutes of start of treatment and any time during treatment. •The time to request for rescue medication. •The time to first pain relief. •The number of inhalations taken before first pain relief and whether the patient covered the hole in the Inhaler during inhalation. •Global medication performance assessment by patient, clinician and research nurse: 0 = poor to 4 = excellent, measured after completion of treatment. •Evaluation of adverse events (AEs) experienced during treatment, not associated with the underlying minor trauma. •Evaluation for any change in vital signs and sedation score during treatment. •Evaluation of AEs at 14 ± 2 days following ED discharge using follow-up questionnaire that includes high output nephrotoxicity. ;Timepoint(s) of evaluation of this end point: As specified within the descriptions of the endpoints above.	—

Measure

Time frame

Secondary end point(s): •Responder analysis – number and percentage of responders, who achieve 30% reduction in VAS score compared to baseline, at 15 minutes. •Responder analysis – exploratory: number and percentage of responders who achieve 30% reduction in VAS score compared to baseline at 5, 10 and 20 minutes. •Change in pain intensity as measured using VAS from baseline to 5, 10, 15, 20 and 30 minutes, followed by a 30-minute interval thereafter until the point of ED discharge/in-patient admission decision. •Rescue medication requested within 20 minutes of start of treatment and any time during treatment. •The time to request for rescue medication. •The time to first pain relief. •The number of inhalations taken before first pain relief and whether the patient covered the hole in the Inhaler during inhalation. •Global medication performance assessment by patient, clinician and research nurse: 0 = poor to 4 = excellent, measured after completion of treatment. •Evaluation of adverse events (AEs) experienced during treatment, not associated with the underlying minor trauma. •Evaluation for any change in vital signs and sedation score during treatment. •Evaluation of AEs at 14 ± 2 days following ED discharge using follow-up questionnaire that includes high output nephrotoxicity. ;Timepoint(s) of evaluation of this end point: As specified within the descriptions of the endpoints above.

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Countries

Ireland, United Kingdom

Contacts

Public ContactDirector, Scientific Affairs

Medical Developments International Limited

regulatory@medicaldev.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026