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

Acute Traumatic Pain Clinical Trial

— Morphine-Mida  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731184
• Other study ID #: Morphine Midazolam
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2012
• Last updated: November 16, 2012
• Start date: November 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2012
• Source: Centre Hospitalier de Cornouaille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Acute Traumatic Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	CH de Carhaix	Carhaix
France	CHU de Nantes	Nantes
France	Centre Hpistalier Intercommunal de Cornouaille	Quimper

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Cornouaille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	The primary outcome was the proportion of patients with a pain score less than or equal to 3 after 20 minutes	20 minutes	No
Secondary	pain evolution	The secondary outcomes were in between-group comparison of: - pain score every 5 minutes during 30 minutes	every 5 minutes and at the end of the study	No
Secondary	Safety	The secondary outcomes were in between-group comparison of: - The treatment safety	during all the study	Yes
Secondary	Morphine total dose	The secondary outcomes were in between-group comparison of: - The total morphine dose required until obtaining pain score less than or equal to 3	During all the study	No