Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier de Cornouaille
• Collaborator: Ministry of Health, France
• Treatments: Midazolam; Morphine

Criteria

Inclusion Criteria:

• 18 to 70 years old

• conscient with spontaneous ventilation

• acute pain with an traumatic origin : pain escape superior or egal to 6/10

• taking care by French reanimation and urgency mobile services (Smur).

Exclusion Criteria:

• younger than 18 years old or older than 70 years old

• chronical respiratory insufficiency

• severe hepatocellular insufficiency,

• myasthenia

• known allergy to morphine or benzodiazepin,

• already treated for a chronical pain,

• pregnant women

• treated by morphine

• patient unable to evaluate his/her pain

• any acute and severe hemodynamic, respiratory or neurologic deficiency

• needed an local analgesia

• patient who received an other antalgic treatment