Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00237731
First received: October 7, 2005
Last updated: February 25, 2010
Last verified: February 2010

October 7, 2005
February 25, 2010
September 2005
March 2006   (final data collection date for primary outcome measure)
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Same as current
Complete list of historical versions of study NCT00237731 on ClinicalTrials.gov Archive Site
  • Time to obtain an analgesia, defined by a VRS < or = 30
  • Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
  • Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
  • Safety evaluation
Same as current
Not Provided
Not Provided
 
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be followed during the study until 60 minutes.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Severe, Acute Pain in a Pre-hospital Setting
  • Drug: morphine
    morphine 0.05
  • Drug: morphine
    morphine 0.10
  • Experimental: 1
    morphine 0.05
    Intervention: Drug: morphine
  • Active Comparator: 2
    morphine 0.10
    Intervention: Drug: morphine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe, acute pain defined by a VRS of 60/100 or higher
  • Male or female over 18 years
  • Cared by a medical emergency care unit
  • Written informed consent
  • Affiliated to social security

Exclusion Criteria:

  • A known opioid or paracetamol hypersensitivity
  • Patient not agree ta participate at the study
  • Pregnancy
  • Uncontrolled epilepsia
  • Incapacity to understand the VRS
  • Renal, respiratory, or liver disease
  • Patients who have received sedative drugs or alcohol (< 6h)
  • Acute respiratory, haemodynamic or neurologic failure
  • Patients who have already received an analgesic (< 6h)
  • Drug addiction
  • Patients under protection of justice
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00237731
0505103
No
Roques, UHToulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Jean-Louis DUCASSE University Hospital Toulouse, FRANCE
University Hospital, Toulouse
February 2010

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