International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors. (EI Morphinique)
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Purpose
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.
| Condition |
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To Describe and to Analyze Factors Predicting Adverse Events in Patients Receiving Morphine for Acute Pain in an Emergency Setting. |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 910 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients aged 18 years or older who require treatment with morphine for pain control
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.
Contacts and Locations| Contact: Vincent Bounes, MD | 05 67 69 16 75 ext 33 | bounes.v@chu-toulouse.fr |
| Contact: Vanessa Houze-Cerfon, MPH | 05 67 69 16 02 ext 33 | house-cerfon.v@chu-toulouse.fr |
| France | |
| University Hospital Toulouse | Recruiting |
| Toulouse, Midi-Pyrénées, France, 31052 | |
| Contact: Vanessa Houze-Cerfon, MPH 05 67 69 16 02 ext 33 house-cerfon.v@chu-toulouse.fr | |
| Contact: Béatrice Appiah, MPH 05 67 69 16 02 ext 33 appiah.b@chu-toulouse.fr | |
| Sub-Investigator: Jean Louis Ducassé, MD | |
| Sub-Investigator: Michael Ganetsky, MD | |
| Principal Investigator: | Vincent Bounes, MD |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01654055 History of Changes |
| Other Study ID Numbers: | 1243803 |
| Study First Received: | July 27, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University Hospital, Toulouse:
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Morphine - Adverse events - Predictive factors |
Additional relevant MeSH terms:
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Emergencies Drug Toxicity Disease Attributes Pathologic Processes Poisoning Substance-Related Disorders Morphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013