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

Sponsor:	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

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

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

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

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

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:	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 - French Health Products Safety Agency

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 February 09, 2012