International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors. (EI Morphinique)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital, Toulouse.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01654055
First received: July 27, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

Morphine is the gold standard for treatment of severe acute pain but it has a number of adverse effects.

No study has so far managed to identify the morphine-induced adverse drug reactions. The primary objective of this study is to determine predictive factors of morphine-induced adverse drug reaction when it is used in emergency departments.


Condition
To Describe and to Analyze Factors Predicting Adverse Events in Patients Receiving Morphine for Acute Pain in an Emergency Setting.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Occurrence of morphine related adverse-event [ Time Frame: From the administration of morphine until 6 hours after this first administration ] [ Designated as safety issue: Yes ]
    The primary outcome variable will be defined as occurrence of morphine related adverse-event (including nausea, dizziness, emesis, drowsiness, pruritus, respiratory distress and death)


Secondary Outcome Measures:
  • Description of adverse effects caused by morphine [ Time Frame: For each side effects of morphine from the first administration of morphine until 6 hours after. ] [ Designated as safety issue: Yes ]
    Description of adverse effects caused by morphine, initial and final pain scores and support given by centres. Imputability scores will be evaluated for each event.


Estimated Enrollment: 910
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

We want to study a large cohort of morphine-induced adverse drug reactions patients, the consequences for patients, mainly in terms of severity, and predictive criteria. This will allow us to identify some patients most at risk of morphine-induced adverse drug reactions, and thus to adapt morphine titration and monitoring of these patients. Leading to a better understanding and a better prediction of adverse effects in patients, it is possible that part of the "opiophobia" which persists in emergency services disappear. Finally, it is toward a better security but also a better efficiency in the management of pain patients in emergencies that leads this study.

The secondary objectives are:

To determine the frequency and severity of adverse events related to morphine. To establish an inventory of morphine use in emergency departments in the different centres studied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients aged 18 years or older who require treatment with morphine for pain control

Criteria

Inclusion Criteria:

All patients aged 18 years or older who require treatment with morphine for pain control will be considered for entry into the study.

Conscious without life threatening at the inclusion

Exclusion Criteria:

Patients who receive morphine during or after an orotracheal intubation, altered level of consciousness, inability to give consent or refusal of patient.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654055

Contacts
Contact: Vincent Bounes, MD 05 67 69 16 75 ext 33 bounes.v@chu-toulouse.fr
Contact: Vanessa Houze-Cerfon, MPH 05 67 69 16 02 ext 33 house-cerfon.v@chu-toulouse.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, Midi-Pyrénées, France, 31052
Contact: Vanessa Houze-Cerfon, MPH    05 67 69 16 02 ext 33    house-cerfon.v@chu-toulouse.fr   
Contact: Béatrice Appiah, MPH    05 67 69 16 02 ext 33    appiah.b@chu-toulouse.fr   
Sub-Investigator: Jean Louis Ducassé, MD         
Sub-Investigator: Michael Ganetsky, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Vincent Bounes, MD
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01654055     History of Changes
Other Study ID Numbers: 1243803
Study First Received: July 27, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital, Toulouse:
Morphine - Adverse events - Predictive factors

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014