Skip to main content
OpenTrials
Completed

NCT Number: NCT01731184

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Brest, Brest, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).

Other names: Midazolam (hypnovel)

Primary outcomes

  1. Pain score

    Time frame: 20 minutes

    The primary outcome was the proportion of patients with a pain score less than or equal to 3 after 20 minutes

Secondary outcomes

  1. pain evolution

    Time frame: every 5 minutes and at the end of the study

    The secondary outcomes were in between-group comparison of:

    • pain score every 5 minutes during 30 minutes
  2. Safety

    Time frame: during all the study

    The secondary outcomes were in between-group comparison of:

    • The treatment safety
  3. Morphine total dose

    Time frame: During all the study

    The secondary outcomes were in between-group comparison of:

    • The total morphine dose required until obtaining pain score less than or equal to 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cornouaille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.

Acronym: Morphine-Mida

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Nov 21, 2012
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.