Pre-Hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg - Full Text View

Sponsored by:	University Hospital, Toulouse
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00237731

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pre-Hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

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

Estimated Enrollment:	106
Study Start Date:	September 2005
Estimated Study Completion Date:	January 2006
Estimated Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental morphine 0.05	Drug: morphine morphine 0.05
2: Active Comparator 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

Contacts

Contact: Jean-Louis DUCASSE, MD	0561772490 ext 33	ducasse.jl@chu-toulouse.fr
Contact: Vincent BOUNES	0561772490	bounes.v@chu-toulouse.fr

Locations

France
SAMU 31 Hôpital PURPAN	Recruiting
TOULOUSE, France, 31059
Contact: Jean-Louis DUCASSE, MD
Principal Investigator: Jean-Louis DUCASSE, MD
Sub-Investigator: Emmanuel VILLACEQUE, MD
Sub-Investigator: Patrick ROUX, MD

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator:

Jean-Louis DUCASSE

University Hospital Toulouse, FRANCE

More Information

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

This link exits the ClinicalTrials.gov site

Publications:

Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine] Ann Fr Anesth Reanim. 1997;16(8):945-9. French.

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

Publications indexed to this study:

Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducassé JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54.

Responsible Party:	UHToulouse ( Roques )
Study ID Numbers:	0505103
Study First Received:	October 7, 2005
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00237731
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

Acute pain
Morphine titration
Analgesia
Pre-hospital care

Study placed in the following topic categories:

Morphine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009