Open randomized clinical trial to compare pain relief between low-dose methoxyflurane and standard of care for the treatment of patients with trauma pain in emergency medical services in the Netherlands
- Conditions
- pijn ten gevolge van traumatrauma pain
- Registration Number
- NL-OMON50181
- Lead Sponsor
- Mundipharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
1. Patients should be * 18 years of age and competent to participate in the
study according to the Investigator*s opinion.
2. Moderate pain (NRS0-10 *4 and *8) secondary to extremity injuries
3. Conscious patients with a stable circulation
A potential subject who meets any of the defined criteria will not be eligible
for participation in this study and will be treated according to SoC. These
criteria will be judged by the Investigator prior to study participation and
will be based on (hetero)anamnesis. The defined criteria are:
1. Known hypersensitivity to MEOF or any fluorinated anaesthetic.
2. Personal or family history of malignant hyperthermia.
3. Patients with known liver disease and patients who have a history of showing
signs of liver damage after previous MEOF use or halogenated hydrocarbon
anaesthesia
4. Known clinically significant renal impairment
5. Known pregnant or likely to be pregnant women at the time of inclusion.
6. Clinically evident cardiovascular instability
7. Clinically evident respiratory depression
8. Treatment with analgesia (with the exception of oral WHO-step 1 analgesics)
prior to arrival of the EMS to reduce pain caused by the trauma.
9. Altered level of consciousness due to any cause, including head injury,
drugs or al-cohol
10. Active alcohol or drug abuse and/or history of opioid abuse
11. Degenerative diseases, mental illness or other conditions that could affect
ability of valuing pain intensity
12. Patients unable to understand the purpose of the study and perform
self-assessments, following investigator*s criteria.
13. Participation in another clinical trial within 30 days prior to
randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in mean pain intensity (NRS) over 10 min:<br /><br>Change from baseline (t=0; first *in study* pain (NRS) assessment on scene) to<br /><br>3, 5 and 10 min using Mixed-Effect Model Repeated Measure (MMRM). </p><br>
- Secondary Outcome Measures
Name Time Method