- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654055
International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments. (EI-Morphinique)
International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors.
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Midi-Pyrénées
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Toulouse, Midi-Pyrénées, France, 31052
- University Hospital Toulouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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From the administration of morphine until 6 hours after this first administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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For each side effects of morphine from the first administration of morphine until 6 hours after.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Bounes, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1243803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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