Study comparing pain relief between low-dose methoxyflurane and the usual treatment in patients with pain due to accidents in the emergency medical services in the Netherlands

Phase 1

• Conditions: Patients with moderate trauma pain due to extremity injuries for whom the emergency medical services have been called.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001601-82-NL
• Lead Sponsor: Mundipharma Pharmaceuticals B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-Patients should be = 18 years of age
-Moderate pain (NRS0-10 =4 and =8) secondary to extremity injuries
-Conscious patients with a stable circulation

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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Hypersensitivity to MEOF or any fluorinated anaesthetic.
-Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
-Patients who have a history of showing signs of liver damage after previous MEOF use or halogenated hydrocarbon anaesthesia
-Known clinically significant renal impairment
-Known pregnant or likely to be pregnant women at the time of inclusion.
-Clinically evident cardiovascular instability
-Clinically evident respiratory depression
-Patients taken any analgesic (excluding oral WHO-step 1 analgesics) for the trauma pain before inclusion
-Altered level of consciousness due to any cause, including head injury, drugs or alcohol
- Active alcohol or drug abuse and/or history of opioid abuse
-Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
-Patients unable to understand the purpose of the study and perform self-assessments, following investigator’s criteria.
-Participation in another clinical trial within 30 days prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified