Methoxyflurane Versus Usual Care for Non-Traumatic Pain in Emergency Departments
ConditionPain Management
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
Pain is one of the most frequent patient-reported symptoms in emergency departments (EDs). Pain management could be very challenging, notably for patients that must wait in an ED waiting room. In such context, antalgic drugs that could be used are mainly oral medications with the paracetamol (acetaminophen), the non-steroidal anti-inflammatory drugs and the weak and strong opioid drugs as the main available options, depending on the degree of pain. Those commonly used painkillers, with oral administration, need a delay (approximatively 20 to 30 minutes) before the full analgesic effect could be observed. Methoxyflurane is a self-administered inhaled analgesic used for over 40 years in countries such as Australia. Methoxyflurane has a rapid onset of action, is well tolerated and is widely used for moderate to severe traumatic pain, with several trials that have investigated it efficacy in such indication. However, no data are available concerning the management of non-traumatic painful diseases. Thus, the aim of the open-label, multicenter, and two parallel-arms superiority PAIN-THROX randomized controlled trial is to assess how using self-administered inhaled Methoxyflurane could reduce the time to pain relief comparatively with oral analgesic medications for patients seeking in an ED for non-traumatic painful diseases and who could wait in an ED waiting room.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult ≥ 18 years
Acute non-traumatic pain of moderate to severe intensity (VAS strictly greater than 39 mm)
Able to independently assess their pain using a VAS and to record it independently on paper.
Affiliated to a social security system
Disqualifiers
Age < 18 years
Hypersensitivity to the active substance or to any other fluorinated anesthetic or to any excipient.
Malignant hyperthermia: known malignant hyperthermia or genetic predisposition.
History of serious adverse reactions (patient or relatives) after administration of inhaled anesthetics.
Trial design
Design model
Parallel
Treatments tested in this trial
Analgesic management with Methoxyflurane as first-line treatment
DrugThe investigational medicinal product is methoxyflurane, presented as a liquid for vapor inhalation, supplied in 3 mL vials and marketed under the name Penthrox®. Each vial contains 3 mL of methoxyflurane at 99.9%, and includes butylated hydroxytoluene (E321) as an excipient with known effect (0.01% w/w). Each pack contains one methoxyflurane vial, an inhaler, and an activated carbon chamber. Methoxyflurane is self-administered under the supervision of a trained healthcare professional, either a physician or a nurse. Administration is performed using the provided handheld inhaler.
Pain treatment according to the usual analgesic management protocol of the emergency department of the participating center.
DrugAdministration of oral analgesic treatment in the emergency reception area according to the protocol in force in the emergency department.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Time to Pain Reduction of at Least 30 mm on the Visual Analog Scale (VAS)
Time from randomization to the first decrease of at least 30 mm from baseline pain score measured on a 100-mm Visual Analog Scale (VAS), assessed within the 30 minutes after randomization. The VAS is a simple pain measurement tool consisting of placing a mark on a colored ruler graduated in millimeters, thereby associating a numerical value ranging from 0 (no pain) to 100 millimeters (unbearable pain).
Time frame
At Inclusion An at 3, 5, 10, 15, 20, 25, and 30-minutes post randomisationSecondary outcomes
1
Evaluate the effect of methoxyflurane based on pain intensity
Assess the effect of methoxyflurane in each of the three subgroups defined by pain intensity and categorized as "moderate" pain (VAS between 40 and 59), "severe" pain (VAS between 60 and 79 mm), and "unbearable" pain (VAS ≥ 80 mm) at enrollment
Time frame
from baseline to 30 minutes after randomization2
Compare the prolonged analgesic effect (ranging from 30 minutes to 2 hours) of methoxyflurane
Compare the prolonged analgesic effect of methoxyflurane with that of "standard"pain management with the measurement of Pain Intensity (VAS) at 60, 90, and 120 Minutes Post-Randomization
Time frame
At 60 minutes after randomization, 90 minutes and 120 minutes3
Use of Rescue Analgesic Treatment After 30 Minutes Post-Randomization
Participants requiring any analgesic treatment due to insufficient pain relief or recurrence of pain more than 30 minutes after randomization.
Time frame
More than 30 minutes after randomization4
Class of Rescue Analgesic Treatment Used After 30 Minutes Post-Randomization
Therapeutic class of the analgesic treatment administered for insufficient pain relief or recurrence of pain more than 30 minutes after randomization.
Time frame
More than 30 minutes after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: