Trauma Pain MedDRA version: 19.1 Level: PT Classification code 10065016 Term: Post-traumatic pain System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 19.1 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Penthrox 3 ml inhalation vapour liquid
Product Name: Penthrox 3ml vapour liquid
Product Code: ME-MEOTH
Pharmaceutical Form: Inhalation vapou
Sponsors
Mundipharma Pharmaceuticals, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Adult patients: = 18 years of age - Moderate to severe pain (NRS0-10 = 4) secondary to trauma - Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay = 12h) - Conscious patient. - Giving informed consent in writing 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 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 310
Exclusion criteria
Exclusion criteria: - Hypersensitivity to Metoxiflurane 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 Metoxiflurane 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 for the traumatic pain before inclusion - Altered level of consciousness due to any cause, including head injury, drugs or alcohol - Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity - Patients to be 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 |
|---|---|
| Main Objective: Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief; Secondary Objective: - Analgesic efectiveness - Speed of action of analgesia (from randomisation (R) to STA) - Preparation + administration time and complexity - Safety - Cost - Investigator and patients satisfaction - Patient and investigators fulfillement of expectations - Patients Global impression of change - Request of rescue medication - Treatment cost per pain relief by time unit - Time from R and STA to pain relief - Number of patients achieving pain intensity NRS0-10= 20 min - Request of rescue medication - Safety: rates of Adverse Events ;Primary end point(s): - Pain Intensity measure by Numeric Scale (0-10);Timepoint(s) of evaluation of this end point: At 0, 3, 5, 10, 15 and 20 minutes after medicine administration and at discharge time | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Investigator and patients satisfaction measured as convenience, treatment efficacy and adverse event - Patients and investigators' fulfillment of expectation: - Patients' Globlal impression of change. - Rescue Medication - Adverse Events during the study - Total time required in the treatment, as well as the fungible materials used and their cost. ;Timepoint(s) of evaluation of this end point: At 0, 3, 5, 10, 15, 20, 30, 40, 50 and 60 minutes after medicine administration, at hopital discharge and 14 days (+/2) after hospital discharge (this last time only for safety data) | — |
Countries
Spain
Contacts
Public ContactUCICEC
Hospital Universitario La Paz
Outcome results
None listed