UnknownPhase 3

Inhaled Methoxyflurane for Pain Management in Nasal Bone Fracture Reduction

Canada34 participantsStarted 2019-10-10

Plain-language summary

This is a randomised, double-blind, placebo controlled study to evaluate the efficacy of Methoxyflurane (Penthrox®) for the treatment of acute pain during closed nasal fracture reduction. The study aims to provide evidence under blinded controlled conditions that Penthrox is safe and effective in patients aged 18 to 65 years during closed nasal fracture reduction.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Being a man or a woman between 18 and 75 years old, inclusively ; and * Being covered by the Quebec medical insurance (RAMQ); and * Presenting an uncomplicated nasal fracture requiring a delayed (7 to 10 days) closed reduction. Exclusion Criteria: * Pregnant or breastfeeding woman; or * Known for renal insufficiency (DFG \< 50) ; or * Known for hepatic impairment; or * Personal or familial allergies/hypersensitivity to fluorinated products; or * Contraindications to local anesthesia (including allergies); or * Personal or family history of malignant hyperthermia; or * Other facial fractures and/or significant injuries; or * Altered state of consciousness (dementia, drug intoxication, head trauma or other similar psychologic disorder); or * Significant respiratory impairment; or * Haemodynamic instability; or * Simultaneous use of alcohol, isoniazid, phenobarbital, rifampin, opioids, sedatives, hypnotics, sedative antihistaminics, general anesthetics, phenothiazines, tranquilizers, myorelaxants, nephrotoxic antibiotics (tetracycline, gentamicin, colistine, polymyxin B, amphotericin B); or * Use of cannabis or other illicit drugs the day of the procedure; or * Use of pain medication in past 6 hours; or * Use of Methoxyflurane : more than 6 mL in the last 48 hours or more than 15 mL in the last week or usage in the last 3 months; or * Need of sedation or general anesthesia for the procedure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain level variation during nasal closed reduction: visual analog scale

Timeframe: The "baseline pain" will be assessed before local anesthesia will be administered (at the very beginning of the procedure), whereas the "mean pain" and the "peak pain" will be assessed after the closed reduction is completed.

Trial details

NCT IDNCT04332159

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

Contact for this trial

Pierre-Hugues Fortier, M.D. FRCSC

8193461110 Pierre-Hugues.Fortier@USherbrooke.ca

View on ClinicalTrials.gov More Pain, Acute trials