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International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments. (EI-Morphinique)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: July 27, 2012
Last updated: December 22, 2015
Last verified: December 2015

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.

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.

Enrollment: 1128
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: August 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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.

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Please refer to this study by its identifier: NCT01654055

University Hospital Toulouse
Toulouse, Midi-Pyrénées, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Vincent Bounes, MD
  More Information

Responsible Party: University Hospital, Toulouse Identifier: NCT01654055     History of Changes
Other Study ID Numbers: 1243803 
Study First Received: July 27, 2012
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acute Pain
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 25, 2016