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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier de Cornouaille
ClinicalTrials.gov Identifier:
NCT01731184
First received: November 13, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Traumatic Pain
 Drug: Midazolam
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier de Cornouaille:

Primary Outcome Measures:
  • Pain score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    The primary outcome was the proportion of patients with a pain score less than or equal to 3 after 20 minutes


Secondary Outcome Measures:
  • pain evolution [ Time Frame: every 5 minutes and at the end of the study ] [ Designated as safety issue: No ]

    The secondary outcomes were in between-group comparison of:

    - pain score every 5 minutes during 30 minutes


  • Safety [ Time Frame: during all the study ] [ Designated as safety issue: Yes ]

    The secondary outcomes were in between-group comparison of:

    - The treatment safety


  • Morphine total dose [ Time Frame: During all the study ] [ Designated as safety issue: No ]

    The secondary outcomes were in between-group comparison of:

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



Enrollment: 100
Study Start Date: November 2006
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midazolam
Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
 Drug: Midazolam
Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
Other Name: Midazolam (hypnovel)
Placebo Comparator: Placebo
Placebo at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731184

Locations
France
CHU de Brest
Brest, France, 29609
CH de Carhaix
Carhaix, France, 29270
CHU de Nantes
Nantes, France, 44000
Centre Hpistalier Intercommunal de Cornouaille
Quimper, France, 29000
Sponsors and Collaborators
Centre Hospitalier de Cornouaille
Ministry of Health, France
Investigators
Principal Investigator: Yannick AUFFRET, Dr Centre Hospitalier intercommunal de Cornouaille
  More Information

No publications provided

Responsible Party: Centre Hospitalier de Cornouaille
ClinicalTrials.gov Identifier: NCT01731184     History of Changes
Other Study ID Numbers: Morphine Midazolam
Study First Received: November 13, 2012
Last Updated: November 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier de Cornouaille:
acute traumatic pain, pre-hospital setting, Midazolam

Additional relevant MeSH terms:
Midazolam
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013