Acute trauma pain MedDRA version: 20.0 Level: PT Classification code 10072132 Term: Fracture pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Penthrox®
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: metossiflurano
Current Sponsor code: Penthrox®
Other descriptive name: Penthrox®
Concentration unit: ml millilitre(s)
Sponsors
MUNDIPHARMA PHARMACEUTICALS SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be provided by each patient prior to any study-specific activity. In cases where the patient is unable to write autonomously, it must be obtained a verbal consent in presence of a witness that the patient will have to confirm autonomously as soon as (s)he is able • Stable, vigilant and collaborative patient i.e. able to understand and communicate with the examiner in order to carry out the study activities • Age = 18 years • Trauma to the limbs (fracture, dislocation, crushing, bruising) in a single district. N.B. For recruiting, given the particular setting, no instrumental confirmation is required but suspicion of involvement of a single district is sufficient. • Moderate to severe pain, detected by the Numerical Rating Scale (NRS score =4) Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: • Personal or family history (parents or siblings) for malignant hyperthermia. • History of severe adverse reactions to inhaled anesthetics. • History of renal failure • history of liver failure. • trauma risky dynamics (ejection from the vehicle, cabin deformation, death of an occupant of the same vehicle, motor vehicle / pedestrian or cyclist impact with a motor vehicle in motion, projection / overturn, fall from a height of> 3 meters, extraction on event place > 20 min). • Altered level of vigilance and / or conscience (GCS 20 and SatO2 in air <95% • Known pregnancy status.Note: a 1 day delay with respect to the planned menstruation date (28days since the beginning of the previous one) has to be considered a suspected pregnancy. • Hypersensitivity to methoxyflurane, to any fluorinated anesthetic or to the E321 butylhydroxytoluene excipient. • Current treatment with any analgesic for chronic pain or in the previous 5 hours (8 hours in the case of diclofenac). • Known allergy to both paracetamol and non-steroidal anti-inflammatory drugs or known hypersensitivity to morphine •All types of acute abdomen and paralytic ileus •Hearth failure •Recent (within2 months) biliary tract surgery •Current bronchial asthma attack •Uncontrolled epilepsy •Depressive state treated with IMAO (ongoing or interrupted less 3 wks ago) •Theatment with naltrexone •History of active or recurrent peptic ulcer/hemorrhage (2 or more episodes of documented ulceration or bleeing in the last 6 months) •Bleeding diathesis •Current Intensive diuretic therapy •Chronic dyspepsia, gastritis with significant episodes in the last 2 months •Leucopenia and thrombocytopenia, current hemorrhages •Current anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of Penthrox® in treating acute traumatic pain associated with moderate-to-severe pain defined on the NRS scale, comparing it to those of the drugs that currently represent the standard of care in Italy: 1) intravenous morphine for the treatment of severe pain (NRS = 7); 2) intravenous paracetamol or ketoprofen for the treatment of moderate pain (NRS 4-6). ;Secondary Objective: • demonstrate that the efficacy of Penthrox® is superior to that of standard care in treating acute pain (within 10 minutes) of moderate to severe degree • compare the efficacy of Penthrox® vs the standard of care in terms of use of additional analgesia (rescue medication) in acute • compare the efficacy of Pentrox® vs. the standard of care in treating acute pain (after 15, 20, 25, 30 minutes) of moderate to severe degree • compare the efficacy of Penthrox® vs the standard of care in terms of rate of onset of the analgesic effect • compare Penthrox® vs the standard of care in terms of efficacy according to patient judgment and ease of use according to the healthcare provider's judgment • to assess the safety and tolerability of Penthrox® and comparator treatments (standard of care);Primary end point(s): The primary endpoint of the study is the change in the intensity of pain from baseline to 10 minutes later (3, 5, 10 minutes), evaluated overall without distinction of pain class (moderate + severe) and only in patients with moderate pain in the two treatment arms;Timepoint(s) of evaluation of this end point: BASELINE AND 3, 5, 10 MINUTES LATER | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 • Pain intensity variation from randomization (baseline) up to 10 minutes (3, 5, 10 minutes) evaluated overall without distinction of pain class (moderate + severe) in each of the two treatment arms 2 • Percentage of patients who are using rescue medication within 30 minutes in each of the two treatment arms 3 • Change in pain intensity from randomization (baseline) to 15, 20, 25, 30 minutes after evaluated overall without distinction of pain class (moderate + severe) in each of the two treatment arms 4 • Time to get relief from pain starting from randomization, evaluated overall without distinction of pain class (moderate + severe), in each of the two treatment arms 5 • Assessment of the therapy efficacy as perceived by patient and measured by Likert scale 30 minutes after randomization , evaluated overall without distinction of pain class (moderate +severe) in each of the two treatment arms 6 • Evaluation of the practicality of use of therapy evaluated by Likert scale by healthcare staff who administered the treatment, evaluated overall without distinction of pain class (moderate + severe) in each of the two treatment arms 7 • incidence of adverse events (organized for Preferred Term and System Organ Class) and trend of vital signs detected at 10 and 30 minutes after baseline 8 • Pain intensity variation from randomization (baseline) to 3, 5, 10, 15, 20, 25, 30 minutes later, overall without distinction of pain class (moderate + severe) for each type of inclusion trauma in each arm of treatment 9 • percentage of patients who use the dilution hole closure (ONLY TREATED WITH PENTHROX);Timepoint(s) of evaluation of this end point: 1 • BASELINE AND 3, 5, 10 MINUTES LATER 2 • WITHIN 30 MINUTES FROM BASELINE 3 • BASELINE AND 15,20,25,30 MINUTES LATER 4 • WITHIN 30 MINUTES FROM BASELINE 5 • 30 MINUTES FROM BASELINE 6 • 30 MINUTES FROM BASELINE (AS CLOSEST AS POSSIBILE TO TREATMENT CONCLUSION) 7 • WITHIN 14 +/- 2 DAYS FROM BASELINE | — |
Countries
Italy
Contacts
Public ContactResponsabile medico e della conduzi
Mundipharma Pharmaceuticals S.r.l.
Outcome results
None listed