International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors. (EI Morphinique)
Recruitment status was Recruiting
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 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.|
- 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)
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654055
|Contact: Vincent Bounes, MD||05 67 69 16 75 ext firstname.lastname@example.org|
|Contact: Vanessa Houze-Cerfon, MPH||05 67 69 16 02 ext email@example.com|
|University Hospital Toulouse||Recruiting|
|Toulouse, Midi-Pyrénées, France, 31052|
|Contact: Vanessa Houze-Cerfon, MPH 05 67 69 16 02 ext 33 firstname.lastname@example.org|
|Contact: Béatrice Appiah, MPH 05 67 69 16 02 ext 33 email@example.com|
|Sub-Investigator: Jean Louis Ducassé, MD|
|Sub-Investigator: Michael Ganetsky, MD|
|Principal Investigator:||Vincent Bounes, MD|