Severe, Acute Pain in a Pre-hospital Setting
Conditions
Keywords
Acute pain, Morphine titration, Analgesia, Pre-hospital care
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.
Interventions
DRUGmorphine
morphine 0.05
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration | — |
Secondary
| Measure | 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 | — |
Countries
France
Outcome results
None listed