moderate to severe pain secondary to minor trauma MedDRA version: 21.1 Level: PT Classification code 10072132 Term: Fracture pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Penthrox®
Product Name: metossiflurano vaporizzato
Product Code: [metossiflurano vaporizzato]
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Methoxyflurane
CAS Number: 76-38-
Sponsors
MUNDIPHARMA RESEARCH LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years. • •Stable, vigilant and collaborating patient able to understand and communicate with the investigator to perform the study activities. • Minor trauma to the limbs (fracture, dislocation, dislocation, crushing, contusion) in a single district. N.B. for the recruitment, given the particular setting, instrumental confirmation is not required but the suspicion of involvement of a single district is sufficient. • Patient with moderate to severe pain secondary to minor trauma, measured by Numerical Rating Scale (NRS scores =4). • Written informed consent must be given by each patient before any study-specific activity. In cases where the patient is not able to write autonomously, verbal consent must be obtained in the presence of an impartial witness who, as soon as he is able, will be required to confirm independently 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Hypersensitivity to methoxyflurane, to any fluorinated anesthetic or to the excipient Butylhydroxytoluene E321. • Personal or family history (parents or siblings) for malignant hyperthermia. • A history of serious adverse reactions to inhaled anesthetics. • A history of renal failure. • Positive history of liver failure. • Clinically evident cardiovascular instability. • Clinically evident respiratory depression. • Lactation and known or suspected pregnancy condition as reported by the patient. N.B. a delay of only one day is also considered suspect of pregnancy with respect to the scheduled date of menstruation (28 days from the beginning of the last one). • Treatment in progress with any analgesic for chronic pain or in the previous 8 hours. • Acute intoxication by drugs, drugs or alcohol. • Imminent risk of life requiring hospitalization or resuscitation. • Altered vigilance and / or conscience level [Glasgow Coma Scale (GCS) <15]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of Penthrox® in the treatment of acute trauma pain, of moderate-severe pain defined according to the NRS scale, in patients rescued in a hostile environment. Specifically, the study primarily intends to demonstrate that Penthrox® is effective in acute (within 10 minutes) ;Secondary Objective: 1. To evaluate the efficacy of Penthrox® in the treatment of acute (after 5,10,15, 20,30,45 and 60 minutes) of moderate to severe pain. 2. To evaluate the efficacy of Penthrox® in terms of the use of additional analgesia (rescue medication). 3. Evaluate the efficacy of Penthrox® according to the patient's judgment and the practicality of use according to the investigator’s judgment. 4. Evaluate the safety and tolerability of Penthrox®. 5. To evaluate the efficacy of Penthrox® compared to the type of trauma characteristic of the inclusion condition. ;Primary end point(s): The primary endpoint of the study is the change in the intensity of pain from the time the drug is taken up to 10 minutes after evaluated overall without distinction of class of pain (moderate + severe). Specifically, we intend to evaluate the percentage of patients who have achieved a = 30% reduction in pain intensity, measured using the VAS scale, compared to baseline within the first 10 min. from the administration of Penthrox®. ;Timepoint(s) of evaluation of this end point: Baseline and 5, 10 minutes later | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the percentage of patients who achieved a = 30% reduction in pain intensity, measured using the VAS Scale, compared to baseline within the first 10 min. from the administration of Penthrox® and also simultaneously show an NRS score between 0 and 3 after the first ten minutes.; Assess changes in pain intensity after 5, 10, 15, 20, and 30 minutes after the first administration of Penthrox® and after 45 and 60 when using the second Penthrox® inhaler.; Evaluate the percentage of patients who achieved a = 50% reduction in pain intensity compared to baseline within the first 10 min. from taking Penthrox®.; Evaluate the intensity of pain when positioning the patient on the spinal axis or on the stretcher; Evaluate the percentage of patients using a second Penthrox® inhaler; Evaluate the percentage of patients who resort to additional analgesia (rescue medication) within 30 minutes of Penthrox® administration; Evaluate the patient's level of satisfaction in terms of effectiveness before being discharged (via Likert scale).; Evaluate the degree of satisfaction of the investigator in terms of practicality detected before the release of the rescue patient (using the Likert scale).; Incidence of adverse events and the progress of the vital signs measured at 10 and 30 minutes and 60 minutes only when using the second Penthrox® inhaler after the baseline.; Evaluate the effectiveness of Penthrox® compared to the type of trauma characteristic of the inclusion condition;Timepoint(s) of evaluation of this end point: Baseline and 5, 10 minutes later; Baseline and 5,10,15,20,30,45,60 minutes later; Baseline and 5, 10 minutes later; Within 30 minutes from the baseline; Within 60 minutes from the baseline; Within 30 minutes from the baseline; Within 30 minutes from baseline, or 60 minutes in case of use of the second inhaler; 30 minutes from baseline, or 60 minutes in case of use of the second inhaler; At 10 and 30 minutes from baseline, or 60 minutes in | — |
Countries
Italy
Contacts
Public ContactResponsabile Medico della conduzion
Mundipharma Pharmaceutical S.r.l.
Outcome results
None listed