Inhaled Methoxyflurane for Pain Management in Nasal Bone Fracture Reduction

NCT04332159 | Unknown Phase 3

• 1 other identifier: CÉR 2020-3355
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain level variation during nasal closed reduction: visual analog scale

  The primary outcome is pain level variation during the closed reduction. Three pain levels will be collected using the visual analog scale : * Pain level before the procedure (or "baseline pain") : will be assessed in order to analyse pain variation during the procedure between the two groups * Mean pain level during the procedure (or "mean pain"), defined as the average amount of pain felt throughout the procedure by the patient * Peak pain level during the procedure (or "peak pain"), defined as the worst pain that the patient had felt during the procedure The visual analog scale is a validated scale on which patients are asked to report their pain level, from zero (absence of pain) to 10 (worst pain imaginable). Pain variation during the procedure will be assessed using two outcome measures : 1. The mean pain due to procedure (the difference between the "mean pain" and the "baseline pain") 2. The peak pain during the procedure, as measured on the visual analog scale

  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.

Secondary Outcomes (5)

• Time needed to achieve the reduction

  The time needed to achieve the reduction will be calculated by subtracting the time at the beginning of the reduction to the time at the end of the reduction, which will be documented by a research nurse during the procedure.

• Rate of participants requesting backup analgesia during the procedure

  Immediately after the intervention

• Reduction failure rate

  Immediately after the intervention

• Pain level during anesthesia: visual analog scale

  Immediately after the intervention

• Number of procedures limited by pain

  Immediately after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Inhalation of Methoxyflurane through a Penthrox inhaler

Procedure: Closed nasal fracture reduction

Control group

PLACEBO COMPARATOR

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

Procedure: Closed nasal fracture reduction

Interventions

Closed nasal fracture reduction PROCEDURE

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre-Hugues Fortier, M.D. FRCSC

CONTACT

8193461110; Pierre-Hugues.Fortier@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo in this study is a 0,9% saline solution that comes in an identical inhaler as the Methoxyflurane. The inhaler for both group will be prepared by the research pharmacist right before the procedure. The characteristic smell of the Methoxyflurane solution will be reproduced by pouring a few drops of Methoxyflurane just above the tip of the inhaler a couple of minutes before the administration of the Methoxyflurane or placebo (will be done for both groups by a pharmacy technician experienced in double-blind research - CIUSSS de l'Estrie-CHUS site Hôtel-Dieu) to make sure that the double-blind design is respected. The pharmacy is located inside the hospital near the outpatient clinic so packages will be easily available within minutes when patients are recruited. In addition, to lower the risk of group identification, a N-95 mask will be worn during each procedure by the investigators and the research nurse.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Clinical professor, Otolaryngology and Head & Neck Surgery

Model Details: To reach their objectives, the investigators propose a randomized, double-blind, placebo-controlled study on a sample of patients randomized in two different groups: * Group A (intervention) : Closed nasal fracture reduction under local anesthesia and inhaled Methoxyflurane. * Group B (control) : Closed nasal fracture reduction under local anesthesia and placebo.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: April 2, 2020
• Study Start: October 10, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 30, 2021
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)