An observational study in Emergencies, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by University Hospital, Toulouse · Observational
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 1,128 is above the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years or older who require treatment with morphine for pain control
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.
Occurrence of morphine related adverse-event
The primary outcome variable will be defined as occurrence of morphine related adverse-event (including nausea, dizziness, emesis, drowsiness, pruritus, respiratory distress and death)
Time frame: From the administration of morphine until 6 hours after this first administration
Description of adverse effects caused by morphine
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.
Time frame: For each side effects of morphine from the first administration of morphine until 6 hours after.
Plan to share: No
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse