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

NCT ID: NCT02152176

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-02-29

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).

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Controlled Analgesy group

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.

Group Type: EXPERIMENTAL

Titration of morphine by Patient Controlled Analgesy

Intervention Type: DEVICE

PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Titration of morphine by Patient Controlled Analgesy

PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROY Pierre-Marie, MD-PhD

Role: STUDY_CHAIR

UH Angers

SCHOTTE Thibault, Physician

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

SCHOTTE Thibault

Angers, , France

CHOUKROUN Jacques

Le Mans, , France

Countries

France

Other Identifiers

AOI 2013-08

Identifier Type: -

Identifier Source: org_study_id