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

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Device: Titration of morphine by Patient Controlled Analgesy

• Registration Number: NCT02152176
• Lead Sponsor: University Hospital, Angers

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Study Start: 2014-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Controlled Analgesy group	Titration of morphine by Patient Controlled Analgesy	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale <30	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 Outcome Measures

Name	Time	Method
Satisfaction	4h	* patient satisfaction; * nurse satisfaction; * time to prepare morphine titration
Evaluate the effectiveness in the group Patient Controlled Analgesy	4h	* time to obtain effective analgesia from prescirption; * consumption of morphine; * Visual Analog Scale evolution; * percentage of patients relieved defined by VAS \<40, 1 hour after the prescription of opioid titration

Trial Locations

Locations (2)

SCHOTTE Thibault; 🇫🇷 Angers, France

CHOUKROUN Jacques; 🇫🇷 Le Mans, France