Acute limb trauma
Conditions
Interventions
Trade Name: PENTHROX 99,9%
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: METHOXYFLURANE 99.9%
Other descriptive name: METHOXYFLURANE 99.9%
Concentration unit: ml millilitre(s)
Co
Sponsors
CHU Brugmann
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Acute trauma to the limbs (upper and/or lower) - =18 years and patients unable to hold the inhaler optimally - Minimum Glasgow: 15/15 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Hemodynamic instability - Pregnancy/breastfeeding - Known allergy to Methoxyflurane - Respiratory failure - Hepatic insufficiency - Chronic renal failure - Tracheostomy and tracheotomy - Confusion - Glasgow less than 15/15
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Measurement of pain with a VAS scale. ;Timepoint(s) of evaluation of this end point: 5, 15, 30, and 60 minutes after administration of Methoxyflurane. Optimal time at 5 min after administration of Methoxyflurane.;Main Objective: Administer the Methoxyflurane using an aerosol nebulizer mask (versus inhalator) and assess whether traumatic pain is relieved.;Secondary Objective: Study the kinetics of pain reduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measurement of pain with a VAS scale.;Timepoint(s) of evaluation of this end point: 5, 15, 30, and 60 minutes after administration of Methoxyflurane. | — |
Countries
Belgium
Contacts
Public ContactEmergency Department
CHU Brugmann
Outcome results
None listed