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

NCT02152176 | Completed Phase 4 DMC

• 1 other identifier: AOI 2013-08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

pain; analgesia; morphine; PCA; Nurse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the effectiveness in the group Patient Controlled Analgesy

  4h

• Satisfaction

  4h

Other Outcomes (1)

• Assess the safety in the group Patient Controlled Analgesy

  4h

Study Arms (2)

Patient Controlled Analgesy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Titration of morphine by Patient Controlled Analgesy DEVICE

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

Patient Controlled Analgesy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to an emergency department
• Acute pain (Visual Analog Scale \> 60)
• Able to assess pain using the numerical scale
• Prescription of morphine titration

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

SCHOTTE Thibault

Angers, 49933, France

Location

CHOUKROUN Jacques

Le Mans, France

Location

MeSH Terms

Conditions

Acute Pain; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• ROY Pierre-Marie, MD-PhD

  UH Angers

  STUDY CHAIR

• SCHOTTE Thibault, Physician

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

FR (2)