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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe, Acute Pain in a Pre-hospital Setting

Intervention / Treatment
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* Drug: morphine
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>morphine 0.05 | Drug: morphine<br>* morphine 0.05<br>|
| Active Comparator: 2<br>morphine 0.10 | Drug: morphine<br>* morphine 0.10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pain, Morphine titration, Analgesia, Pre-hospital care