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)

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.

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 Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Device: Titration of morphine by Patient Controlled Analgesy

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • SCHOTTE Thibault
  • Le Mans, France
    • CHOUKROUN Jacques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale <30	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')	30min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness in the group Patient Controlled Analgesy	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	4h
Satisfaction	patient satisfaction; nurse satisfaction; time to prepare morphine titration	4h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the safety in the group Patient Controlled Analgesy	adverse events du to morphine; adverse events du to medical/nursing support	4h

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Chair: ROY Pierre-Marie, MD-PhD, UH Angers; Principal Investigator: SCHOTTE Thibault, Physician, UH Angers

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Nurse; PCA; pain; morphine; analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: AOI 2013-08