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

Primary Purpose

Severe, Acute Pain in a Pre-hospital Setting

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
morphine
morphine
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe, Acute Pain in a Pre-hospital Setting focused on measuring Acute pain, Morphine titration, Analgesia, Pre-hospital care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SAMU 31 Hôpital PURPAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

morphine 0.05

morphine 0.10

Outcomes

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

Full Information

First Posted
October 7, 2005
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00237731
Brief Title
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Official Title
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe, Acute Pain in a Pre-hospital Setting
Keywords
Acute pain, Morphine titration, Analgesia, Pre-hospital care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
morphine 0.05
Arm Title
2
Arm Type
Active Comparator
Arm Description
morphine 0.10
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
morphine 0.05
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
morphine 0.10
Primary Outcome Measure Information:
Title
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Secondary Outcome Measure Information:
Title
Time to obtain an analgesia, defined by a VRS < or = 30
Title
Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Title
Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Title
Safety evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis DUCASSE
Organizational Affiliation
University Hospital, Toulouse, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMU 31 Hôpital PURPAN
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
9750642
Citation
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. doi: 10.1016/s0750-7658(97)82142-9. French.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
18272093
Citation
Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse 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. doi: 10.1016/j.ajem.2007.04.020.
Results Reference
result
Links:
URL
http://www.orumip.fr
Description
Observatoire Régional Urgences Midi-Pyrénées, Rapport annuel sur l'activité des services d'urgence 2004

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

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