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Completed

NCT Number: NCT01654055

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, Midi-Pyrénées, 31052, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Occurrence of morphine related adverse-event

    Time frame: 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 outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: EI-Morphinique

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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