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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)

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Titration of morphine by Patient Controlled Analgesy
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring pain, analgesia, morphine, PCA, Nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SCHOTTE Thibault
  • CHOUKROUN Jacques

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Controlled Analgesy group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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')

Secondary Outcome Measures

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
Satisfaction
patient satisfaction nurse satisfaction time to prepare morphine titration

Full Information

First Posted
May 22, 2014
Last Updated
June 29, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02152176
Brief Title
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
Acronym
TACIDOU
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
pain, analgesia, morphine, PCA, Nurse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Controlled Analgesy group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
Titration of morphine by Patient Controlled Analgesy
Intervention Description
PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.
Primary Outcome Measure Information:
Title
Visual Analog Scale <30
Description
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')
Time Frame
30min
Secondary Outcome Measure Information:
Title
Evaluate the effectiveness in the group Patient Controlled Analgesy
Description
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
Time Frame
4h
Title
Satisfaction
Description
patient satisfaction nurse satisfaction time to prepare morphine titration
Time Frame
4h
Other Pre-specified Outcome Measures:
Title
Assess the safety in the group Patient Controlled Analgesy
Description
adverse events du to morphine adverse events du to medical/nursing support
Time Frame
4h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROY Pierre-Marie, MD-PhD
Organizational Affiliation
UH Angers
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
SCHOTTE Thibault, Physician
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
SCHOTTE Thibault
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHOUKROUN Jacques
City
Le Mans
Country
France

12. IPD Sharing Statement

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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

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