NCT01731184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2006

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

November 13, 2012

Last Update Submit

November 16, 2012

Conditions

Acute Traumatic Pain

Keywords

acute traumatic pain, pre-hospital setting, Midazolam

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • pain evolution

    every 5 minutes and at the end of the study

  • Safety

    during all the study

  • Morphine total dose

    During all the study

Study Arms (2)

Midazolam

EXPERIMENTAL

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

Drug: Midazolam

Placebo

PLACEBO COMPARATOR

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

Interventions

MidazolamDRUG

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

Also known as: Midazolam (hypnovel)
Midazolam

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Brest

Brest, 29609, France

Location

CH de Carhaix

Carhaix-Plouguer, 29270, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Centre Hpistalier Intercommunal de Cornouaille

Quimper, 29000, France

Location

Related Publications (1)

  • 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.

    PMID: 24613655DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yannick AUFFRET, Dr

    Centre Hospitalier intercommunal de Cornouaille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 21, 2012

Study Start

November 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

FR(4)