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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01654055
First received: July 27, 2012
Last updated: December 22, 2015
Last verified: December 2015

July 27, 2012
December 22, 2015
October 2011
August 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01654055 on ClinicalTrials.gov Archive Site
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.
Same as current
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International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments.
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients aged 18 years or older who require treatment with morphine for pain control
To Describe and to Analyze Factors Predicting Adverse Events in Patients Receiving Morphine for Acute Pain in an Emergency Setting.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1128
August 2012
August 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01654055
1243803
No
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University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Vincent Bounes, MD
University Hospital, Toulouse
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP