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

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ClinicalTrials.gov Identifier: NCT01654055
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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 or disease

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.

Study Type : Observational
Actual Enrollment : 1128 participants
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.
Study Start Date : October 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Primary Outcome Measures :
  1. Occurrence of morphine related adverse-event [ Time Frame: From the administration of morphine until 6 hours after this first administration ]
    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 :
  1. 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. ]
    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.

Information from the National Library of Medicine

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

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): NCT01654055

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

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01654055     History of Changes
Other Study ID Numbers: 1243803
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents