Methoxyflurane Versus Usual Care for Non-Traumatic Pain in Emergency Departments

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

Qualifiers

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

Treatments tested in this trial

  • Analgesic management with Methoxyflurane as first-line treatment
  • Pain treatment according to the usual analgesic management protocol of the emergency department of the participating center.

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators