Study assessing the efficacy and safety of Penthrox® combined with a standard analgesia in comparison to a placebo combined with a standard analgesia in adult patients admitted to the Emergency Department with moderate to severe pain associated with trauma
- Conditions
- Emergency relief of moderate to severe pain associated with trauma in conscious adult patientsMedDRA version: 20.0Level: LLTClassification code 10044461Term: TraumaSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-004469-28-FR
- Lead Sponsor
- MUNDIPHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 360
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>-Compare the safety of Penthrox® + SoC to placebo + SoC <br>-Assess patient sedation<br>-Describe the SoC and concomitant analgesic treatments<br>-Assess the patient/physician/nurse satisfaction (Overall performance of the drug) <br>-Measure the duration of the emergency department stay.<br>-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 Outcome Measures
Name Time Method