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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Traumatic Pain

Keywords

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acute traumatic pain, pre-hospital setting, Midazolam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Midazolam

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Midazolam

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

Intervention Type DRUG

Other Intervention Names

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Midazolam (hypnovel)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yannick AUFFRET, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier intercommunal de Cornouaille

Locations

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CHU de Brest

Brest, , France

Site Status

CH de Carhaix

Carhaix-Plouguer, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Centre Hpistalier Intercommunal de Cornouaille

Quimper, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED

PMID: 24613655 (View on PubMed)

Other Identifiers

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