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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
History of Changes
  Purpose

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


Condition Intervention Phase
Severe, Acute Pain in a Pre-hospital Setting
 Drug: morphine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration

Secondary Outcome Measures:
  • 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

Enrollment: 106
Study Start Date: September 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
morphine 0.05
 Drug: morphine
morphine 0.05
Active Comparator: 2
morphine 0.10
 Drug: morphine
morphine 0.10

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237731

Locations
France
SAMU 31 Hôpital PURPAN
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean-Louis DUCASSE University Hospital Toulouse, FRANCE
  More Information

Additional Information:
Observatoire Régional Urgences Midi-Pyrénées, Rapport annuel sur l'activité des services d'urgence 2004  This link exits the ClinicalTrials.gov site

Publications:
Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Roques, UHToulouse
ClinicalTrials.gov Identifier: NCT00237731     History of Changes
Other Study ID Numbers: 0505103
Study First Received: October 7, 2005
Last Updated: February 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Acute pain
Morphine titration
Analgesia
Pre-hospital care

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013