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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

November 13, 2012
November 16, 2012
November 2006
September 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01731184 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Traumatic Pain
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)
  • Experimental: Midazolam
    Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
    Intervention: Drug: Midazolam
  • Placebo Comparator: Placebo
    Placebo at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
Auffret Y, Gouillou M, Jacob GR, Robin M, Jenvrin J, Soufflet F, Alavi Z. Does midazolam enhance pain control in prehospital management of traumatic severe pain? Am J Emerg Med. 2014 Jun;32(6):655-9. doi: 10.1016/j.ajem.2014.01.048. Epub 2014 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01731184
Morphine Midazolam
No
Centre Hospitalier de Cornouaille
Centre Hospitalier de Cornouaille
Ministry of Health, France
Principal Investigator: Yannick AUFFRET, Dr Centre Hospitalier intercommunal de Cornouaille
Centre Hospitalier de Cornouaille
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP