Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
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.