Morphine Titration by Patient Self-controlled by a Mechanical Device Versus Administration by the Nurse for Patients With Severe Acute Pain in the Emergency Department (TACIDOU)

University Hospital, Angers

Status and phase: Completed; Phase 4

Conditions: Acute Pain

Treatments: Device: Titration of morphine by Patient Controlled Analgesy

Study type: Interventional

Funder types: Other

Identifiers

NCT02152176

AOI 2013-08

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Patient Controlled Analgesy group

Experimental group

Description:

Titration of morphine by Patient Controlled Analgesy. The opioid titration will be performed by the patient using PCA (Vygon Freedom 5) according to the principle of self with a refractory period of 5 minutes.

Treatment:

Device: Titration of morphine by Patient Controlled Analgesy

Control group

No Intervention group

Description:

titration will be perform in the usual manner in accordance with the recommendations : a nurse will assess pain using a visual analog scale in the control group to assess the need for a new bolus of morphine