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

Phase 4

Completed

• Conditions: Severe, Acute Pain in a Pre-hospital Setting
• Interventions: Drug: morphine

• Registration Number: NCT00237731
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	morphine	morphine 0.10
1	morphine	morphine 0.05

Primary Outcome Measures

Name	Time	Method
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration

Secondary Outcome Measures

Name	Time	Method
Time to obtain an analgesia, defined by a VRS < or = 30
Safety evaluation
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)

Trial Locations

Locations (1)

SAMU 31 Hôpital PURPAN; 🇫🇷 Toulouse, France