PHASE IIIb, OPEN LABEL RANDOMISED CLINICAL TRIAL TO COMPARE PAIN RELIEF BETWEEN METHOXYFLURANE AND STANDARD OF CARE FOR TREATING PATIENTS WITH TRAUMA PAIN IN SPANISH EMERGENCY UNITS (InMEDIATE): STUDY PROTOCOL

摘要

ABSTRACT ? Objective: To evaluate efficacy, safety, patient and investigators satisfaction, and cost of pain relief by time unit between methoxyflurane (a volatile anesthetic agent with known analgesic properties, non-opioid, self-administered using a hand-held inhalation device under trained supervision) and emergency analgesic standard of care treatment (SoC), over a period of 30 min from start of administration and time to first pain relief. ? Methods: InMEDIATE is a phase IIIb, randomized, open label, multicenter, parallel group trial. It will be conducted in 15 emergency hospital departments. A total of 310 patients, with moderate to severe pain secondary to trauma, will be randomized to receive either methoxyflurane or SoC. The primary end point of the study is the change in mean pain intensity as measured by a numeric rating scale from randomization to 3, 5, 10, 15 and 20 minutes after treatment administration (using mixed-effect model repeated measure) and time to first pain relief (survival analysis). Discussion: To the best of our knowledge, this is the first randomized trial of methoxyflurane vs active analgesic treatment to be carried out in Europe. The aim of the study is to evaluate the results in terms of efficacy and safety of methoxyflurane for the treatment of traumatic pain in Spanish emergency units (ambulances, emergency primary care, and emergency departments settings), in order to assess the incorporation of this drug into the emergency traumatic pain SoC. Trial Registration: EudraCT, 2017‐000338‐70 Keywords: Methoxyflurane, Inhaled anesthetic, Sedation, Traumatic pain, Emergency units.