A Trial Comparing Different Dosing Regimens of Morphine in Patients With Moderate to Severe Pain
A Randomized Clinical Trial Comparing Different Dosing Regimens of Intravenous Morphine in the Treatment of Adult Patients Presenting to the Emergency Department With Moderate to Severe Pain
1 other identifier
interventional
280
1 country
1
Brief Summary
RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the difference in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg? HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg. SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedFebruary 20, 2006
January 1, 2006
February 17, 2006
February 17, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The between-group difference in mean before-after difference in pain score at baseline and 60 minutes in patients randomized to receive either 0.10 mg/kg or 0.15 mg/kg morphine
Secondary Outcomes (6)
Between-group comparison of mean change in pain score from 30 min to 60 min
Comparison of between-group differences in pain relief scores
Patient satisfaction score
Adverse events at 30 and 60 minutes
Number of additional boluses of analgesics needed within 60 minutes for the two groups.
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may not qualify if:
- Inability or unwillingness to provide informed consent, methadone use, use of other opioids or tramadol within 7 days, prior adverse reaction to morphine, chronic pain syndrome, alcohol intoxication, pregnancy or breast-feeding, systolic blood pressure \<90 mm Hg, use of MAO inhibitors, and weight greater than 100 kg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center Emergency Department
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrienne J. Birnbaum, MD
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 20, 2006
Study Start
March 1, 2005
Study Completion
January 1, 2006
Last Updated
February 20, 2006
Record last verified: 2006-01