Recruiting
Phase 3

Methoxyflurane

Sponsor:

Université de Sherbrooke

Code:

NCT04332159

Conditions

Pain, Acute

Nasal Fracture

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Closed nasal fracture reduction

Study Details

Brief 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.

Conditions

Pain, Acute

Nasal Fracture

Study ID

NCT04332159

Start date

Oct 10, 2019

Status verified date

Apr, 2020

Completion date

Mar 30, 2021

Anticipated

Primary completion date

Mar 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention group

Inhalation of Methoxyflurane through a Penthrox inhaler

placebo comparator: Control group

Inhalation of placebo (0.9% salin solution) through a Penthrox inhaler

Interventions

Closed nasal fracture reduction

Closed nasal fracture reduction is performed under local anesthesia with addition of Methoxyflurane or placebo

Primary outcome measure

  • Pain level variation during nasal closed reduction: visual analog scale [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Pierre-Hugues Fortier, M.D. FRCSC

8193461110Pierre-Hugues.Fortier@USherbrooke.ca

Locations

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Frederic Lemieux-Martel

(819) 346-1110frederic.lemieux-martel@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Apr 7, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2020-04-07.