Titration Morphinique autocontrôlée Par le Patient Par un Dispositif mécanique à Usage Unique Versus Administration Par l'infirmière Chez Les Patients Ayant Une Douleur aiguë sévère Aux Urgences.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Visual Analog Scale <30
Study Overview
Brief Summary
Intense acute pain is a common reason for Emergency admittance and its management is one of the major public health goals.
In the recommendations formalized experts, it is recommended to use a protocol titration with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg) repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.
Despite these specific recommendations and a broad awareness of the teams, management of pain remains to be improved, the major difficulty of morphine titration at the emergency department being the availability of paramedical personnel to perform revaluations and reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.
The investigators want to study the self-controlled morphine titration by the patient by a mechanical device for single use (efficacy/safety).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Admission to an emergency department
- •Acute pain (Visual Analog Scale > 60)
- •Able to assess pain using the numerical scale
- •Prescription of morphine titration
Exclusion Criteria
- •Physical or mental disorders limiting the understanding and / or use of a PCA
- •History of allergy to morphine / hypersensitivity to any component
- •Long-term treatment morphine
- •Opioid therapy administered prior to inclusion
- •Analgesic treatment level 2 (codeine, tramadol, nefopam ...) administered prior to inclusion or planned
- •History of Substance Abuse
- •Severe respiratory insufficiency
- •Severe hepatic impairment
- •Head trauma
- •Intracranial hypertension
- •Uncontrolled epilepsy
- •Pregnant or lactating
- •Patient jailed
- •Incapacitated adult under guardianship
- •Incapable of giving informed consent
Outcomes
Primary Outcomes
Visual Analog Scale <30
Time Frame: 30min
Evaluate the effectiveness of the analgesia of morphine titration self-controlled by the patient using a PCA device for single use ("PCA" group) opposing to an opioid titration carried out by the nurse (group 'Control')
Secondary Outcomes
- Evaluate the effectiveness in the group Patient Controlled Analgesy(4h)
- Satisfaction(4h)