International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors.

Conditions
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Emergencies

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From the administration of morphine until 6 hours after this first administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | For each side effects of morphine from the first administration of morphine until 6 hours after. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine, Adverse events, Predictive factors