The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152176
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Acute Pain Device: Titration of morphine by Patient Controlled Analgesy Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Visual Analog Scale <30 [ Time Frame: 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 :
  1. Evaluate the effectiveness in the group Patient Controlled Analgesy [ Time Frame: 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

  2. Satisfaction [ Time Frame: 4h ]
    • patient satisfaction
    • nurse satisfaction
    • time to prepare morphine titration


Other Outcome Measures:
  1. Assess the safety in the group Patient Controlled Analgesy [ Time Frame: 4h ]
    • adverse events du to morphine
    • adverse events du to medical/nursing support


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152176


Locations
Layout table for location information
France
SCHOTTE Thibault
Angers, France, 49933
CHOUKROUN Jacques
Le Mans, France
Sponsors and Collaborators
University Hospital, Angers
Investigators
Layout table for investigator information
Study Chair: ROY Pierre-Marie, MD-PhD UH Angers
Principal Investigator: SCHOTTE Thibault, Physician UH Angers
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02152176    
Other Study ID Numbers: AOI 2013-08
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Angers:
pain
analgesia
morphine
PCA
Nurse
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents