Acute Traumatic Pain Clinical Trial
Official title:
Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.
Administration of midazolam with morphine in patients with severe acute pain is a routine
practice in the management of pre- and post-operative patients but has not been evaluated in
pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam
in the pre-hospital management of traumatic patients with severe acute pain.
In a multicenter prospective randomized double-blind placebo-controlled trial, the
investigators would like to compare the analgesic effect and safety of the intravenous
morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and
placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a
validated numeric rating scale (NRS).
The primary outcome will be the proportion of patients with a pain score less than or equal
to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the
treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose
required until obtaining a pain score less than or equal to 3.
Patient will be included in pre-hospital setting. They must have an acute pain NRS greater
than or equal to 6 from a traumatic origin. The participation of the study for each patient
will be the time of the pre-hospital setting. The study will stop when the patient arrives
at the hospital.
Patient will be randomized after obtaining an informed consent. Then, the nurse will
administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous
morphine 0.10 mg/kg and placebo.
Only the nurse will be aware of the treatment received by the patient. Every 5 minutes, life
constants and pain score will be recorded on the case report form.
Assessment will be done at the baseline using a validated numeric rating scale. The primary
outcome will be the proportion of patients with a pain score less than or equal to 3 after
20 minutes. The secondary outcomes will be in between-group comparison of: the treatment
safety, pain score every 5 minutes during 30 minutes and the total morphine dose required
until obtaining a pain score less than or equal to 3.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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