Emergency relief of moderate to severe pain associated with trauma in conscious adult patients MedDRA version: 20.0 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 100000004863
Conditions
Interventions
Trade Name: PENTHROX 3 ml liquide avec inhalateur (METHOXYFLURANE)
Pharmaceutical Form: Inhalation vapour, liquid
Pharmaceutical form of the placebo: Inhalation vapour, liquid
Route of administration
Sponsors
MUNDIPHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 or older 2. Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study 3. Patients admitted to the emergency department due to a trauma 4. Patients having a pain score = 4 measured using a numerical scale (NS) at the time of admission to emergency departments 5. Patients having a pain score = 40 measured using the VAS at the time of randomisation 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 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit; 2. Impaired consciousness regardless of the cause, including head trauma or drug or alcohol consumption; 3. Acute medicinal or alcohol intoxication, according to the investigator; 4. Known pregnancy or lactation; 5. Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed; 6. Treatment with nitrous oxide within 5 hours before presentation at the emergency department; 7. Use of analgesics for chronic pain; 8. Prior use of Penthrox®; 9. Use of an investigational product one month before presentation at the emergency department; 10. Hypersensitivity to Penthrox® or any other fluoridated anesthetic; 11. Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions; 12. Clinical evidence of respiratory depression; 13. Clinical evidence of cardiovascular instability; 14. Clinical renal or hepatic damage, according to the investigator, pre-existing or known; 15. Presence of any other clinical condition that can, according to the investigator’s opinion, have an impact on the patient's ability to participate in the study or the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the reduction in time until pain relief of the combination of Penthrox® + standard analgesic (SoC) versus placebo + standard analgesic (SoC) in adult patients admitted into emergency departments with moderate to severe pain associated with a trauma.;Secondary Objective: -Demonstrate a greater reduction of the pain score (measured on a VAS) of Penthrox® + SoC versus placebo + SoC -Compare the safety of Penthrox® + SoC to placebo + SoC -Assess patient sedation -Describe the SoC and concomitant analgesic treatments -Assess the patient/physician/nurse satisfaction (Overall performance of the drug) -Measure the duration of the emergency department stay. -Assess the time until medical decision to discharge;Primary end point(s): The primary endpoint is the time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief (score = 30 on the VAS).;Timepoint(s) of evaluation of this end point: 30 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In relation with the main objective: • Duration between the start of study treatment (T0) and pain relief reported by the patient. • Absolute Pain Intensity Difference (PID) measured using the VAS at 5, 10, 15, 20 and 30 min after T0. PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. • Relative Pain Intensity Difference measured using the VAS at 5, 10, 15, 20 and 30 min after T0. Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. • Pain relief defined by pain intensity 100 beats/min), hypotension (systolic blood pressure [sBP] 180 mm Hg or diastolic blood pressure [dBP] > 100 mm Hg) and respiratory depression (respiratory frequency < 12 respirations/min, oxygen saturation < 92% or need for additional oxygen) • Incidence of premature withdrawal of patients for safety or tolerability reasons;Timepoint(s) of evaluation of this end point: For secondary endpoints in relation with the main objective: 30 minutes For secondary endpoints in relation with the secondary objective: Day 1-day of medical decision to discharge For safety endpoints: Day 15 | — |
Countries
France
Contacts
Public ContactResponsable médical
MUNDIPHARMA
Outcome results
None listed