Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 morphine 0.05 |
Drug: morphine
morphine 0.05
|
| Active Comparator: 2 morphine 0.10 |
Drug: morphine
morphine 0.10
|
Outcome Measures
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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Severe, acute pain defined by a VRS of 60/100 or higher
-
Male or female over 18 years
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Cared by a medical emergency care unit
-
Written informed consent
-
Affiliated to social security
Exclusion Criteria:
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A known opioid or paracetamol hypersensitivity
-
Patient not agree ta participate at the study
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Pregnancy
-
Uncontrolled epilepsia
-
Incapacity to understand the VRS
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Renal, respiratory, or liver disease
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Patients who have received sedative drugs or alcohol (< 6h)
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Acute respiratory, haemodynamic or neurologic failure
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Patients who have already received an analgesic (< 6h)
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Drug addiction
-
Patients under protection of justice
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SAMU 31 Hôpital PURPAN | Toulouse | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Jean-Louis DUCASSE, University Hospital, Toulouse, France
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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
- 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
- 0505103