Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03215056
Eligibility 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.
Note: the range for VAS pain scores was widened from 60 to 80 mm to 55 to 85 mm to improve patient recruitment but very few patients were recruited after that amendment.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03215056
Study Brief:
Protocol Section:
NCT03215056