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

NCT01654055 | Completed

• 1 other identifier: 1243803
• Study Type: observational
• Target: 1,128
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies

Keywords

Morphine; Adverse events; Predictive factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Description of adverse effects caused by morphine

  For each side effects of morphine from the first administration of morphine until 6 hours after.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older who require treatment with morphine for pain control

You may qualify if:

• All patients aged 18 years or older who require treatment with morphine for pain control will be considered for entry into the study.

You may not qualify if:

• Patients who receive morphine during or after an orotracheal intubation, altered level of consciousness, inability to give consent or refusal of patient.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi-Pyrénées, 31052, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Bounes, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)