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NOT YET RECRUITING
NCT07742007
PHASE3

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

Summary

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.

Official title: Methoxyflurane Versus Usual Care for Non-Traumatic Pain in Emergency Departments: the Multicenter, Open-label, Superiority PAIN-THROX Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2026-09-16

Completion Date

2027-09-16

Last Updated

2026-08-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Analgesic management with Methoxyflurane as first-line treatment

The 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.

DRUG

Pain treatment according to the usual analgesic management protocol of the emergency department of the participating center.

Administration of oral analgesic treatment in the emergency reception area according to the protocol in force in the emergency department.

Locations (3)

CHRU Hôpitaux de Tours - Urgences de l'Hôpital Trousseau

Tours, CHRU de Tours, France

CHU d'Angers

Angers, France

CHU d'Orléans

Orléans, France