ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00237731
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 12, 2017
Sponsor:
Information provided by:
University Hospital, Toulouse

Brief Summary:
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 or disease Intervention/treatment Phase
Severe, Acute Pain in a Pre-hospital Setting Drug: morphine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Study Start Date : September 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
morphine 0.05
Drug: morphine
morphine 0.05
Active Comparator: 2
morphine 0.10
Drug: morphine
morphine 0.10



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

Secondary Outcome Measures :
  1. Time to obtain an analgesia, defined by a VRS < or = 30
  2. Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
  3. Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
  4. Safety evaluation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Other 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
SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51
SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7

Responsible Party: Roques, UHToulouse
ClinicalTrials.gov Identifier: NCT00237731     History of Changes
Other Study ID Numbers: 0505103
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents