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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01654055

Acronym

EI-Morphinique

Enrollment

1128

Registered

2012-07-31

Start date

2011-10-31

Completion date

2012-08-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies

Keywords

Morphine, Adverse events, Predictive factors

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of morphine related adverse-event	From the administration of morphine until 6 hours after this first administration	The primary outcome variable will be defined as occurrence of morphine related adverse-event (including nausea, dizziness, emesis, drowsiness, pruritus, respiratory distress and death)

Secondary

Measure	Time frame	Description
Description of adverse effects caused by morphine	For each side effects of morphine from the first administration of morphine until 6 hours after.	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.

Countries

France

Outcome results