Patients with moderate trauma pain due to extremity injuries for whom the emergency medical services have been called.
Conditions
Interventions
Trade Name: Penthrox
Pharmaceutical Form: Inhalation vapour, liquid
Trade Name: paracetamol
Pharmaceutical Form: Solution for infusion
Trade Name: fentanyl
Pharmaceutical Form: Solution for injectio
Sponsors
Mundipharma Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: t=0 (first “in study” pain (NRS) assessment on scene) to 3, 5 and 10 min ;Secondary Objective: Evaluating the analgesic effectiveness (proportion of patients with a clinically relevant reduction of the pain score), speed of onset of analgesia, ease of use, time on scene, transportation costs and safety.;Primary end point(s): Change in mean pain intensity (NRS) over 10 min: Change from baseline (t=0; first “in study” pain (NRS) assessment on scene) to 3, 5 and 10 min using Mixed-Effect Model Repeated Measure (MMRM). ;Main Objective: This study aims at evaluating efficacy (in terms of superiority to) of low-dose methoxyflurane versus standard of care in the treatment of acute pain due to extremity injuries in the emergency medical services in the Netherlands. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in mean pain intensity (NRS) over 5 min Speed of action Proportion of patients with a clinically meaningful reduction in pain intensity score Satisfaction regarding convenience, treatment efficacy and adverse events Fulfilment of expectations Patients’Global Impression of Change Treatment costs of pain relief Safety;Timepoint(s) of evaluation of this end point: depending on the endpoint: Change in mean pain intensity (t=0 (first “in study” pain (NRS) assessment on scene) to 3 and 5 min Speed of action (t=0; first in study pain (NRS) assessment on scene, 3, 5 and 10 min pain (NRS) measurements) Proportion of patients with a clinically meaningful reduction in pain intensity score (t=0 first in study pain (NRS) assessment on scene) and t=10 min pain (NRS) measurements) other parameters will be measured once after 10 minutes, but before transfer to the Emergency Department | — |
Countries
Netherlands
Contacts
Public ContactMedical Manager
RAV Brabant Midden West Noord
Outcome results
None listed