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

Sponsor

Centre Hospitalier de Cornouaille (Other)

Overall Status

Completed

CT.gov ID

NCT01731184

Collaborator

Ministry of Health, France (Other)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Traumatic Pain	Drug: Midazolam	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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).

Arm

Intervention/Treatment

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 Names:

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).

Outcome Measures

Primary Outcome Measures

Pain score [20 minutes]
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 [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
Safety [during all the study]
The secondary outcomes were in between-group comparison of: - The treatment safety
Morphine total dose [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHU de Brest	Brest	France	29609
2	CH de Carhaix	Carhaix	France	29270
3	CHU de Nantes	Nantes	France	44000
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier de Cornouaille

ClinicalTrials.gov Identifier:

NCT01731184

Other Study ID Numbers:

Morphine Midazolam

First Posted:

Nov 21, 2012

Last Update Posted:

Nov 21, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Centre Hospitalier de Cornouaille

acute traumatic pain, pre-hospital setting, Midazolam

Additional relevant MeSH terms:

Acute Pain

Midazolam

Study Results

No Results Posted as of Nov 21, 2012