Status:
COMPLETED
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing...
Detailed Description
The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms: 1. PCA with 1.0 mg morphine demand dosing every 6 minutes, 2. PCA with 1.5 mg demand dosing e...
Eligibility Criteria
Inclusion
- Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
- Age 18 to 65 years
- Patient deemed by the ED attending physician to require IV opioid analgesia
Exclusion
- Current use of prescription or non-prescription opioids
- Long-term use of opioids, chronic pain syndrome
- Clinician suspicion of opioid dependence/abuse
- Clinical suspicion of intoxication
- Pregnancy or breast-feeding
- History of chronic obstructive pulmonary disease, history of sleep apnea, oxygen saturation \< 97%
- Systolic blood pressure \< 100 mm Hg
- Use of monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants
- History of renal insufficiency/renal failure
- Prior allergic reaction to morphine
- Inability to provide informed consent
- Previous entry of patient into study
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00910208
Start Date
April 1 2009
End Date
June 1 2010
Last Update
December 27 2019
Active Locations (1)
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1
Jacobi Medical Center
The Bronx, New York, United States, 10461