Status:
UNKNOWN
Inhaled Methoxyflurane for Pain Management in Nasal Bone Fracture Reduction
Lead Sponsor:
Université de Sherbrooke
Conditions:
Pain, Acute
Nasal Fracture
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 a...
Detailed Description
The main objective of this study is to establish if the addition of Methoxyflurane to local anesthesia has the ability to significantly reduce the pain during closed nasal fracture reduction compared ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04332159
Start Date
October 10 2019
End Date
March 30 2021
Last Update
April 7 2020
Active Locations (1)
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1
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4