- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385541
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
July 16, 2018 updated by: Pamela Flood, Columbia University
The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia
Both morphine and hydromorphone are pain medications commonly used after surgery.
It is thought at the institution that hydromorphone causes less side effects but this has not been studied.
The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia Presbyterian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for abdominal surgery requiring post-operative PCA
- ASA = I or II
Exclusion Criteria:
- preoperative pain or use of pain medication
- narcotic allergy
- morbid obesity (Body Mass Index > 30)
- diagnosis of sleep apnea
- hepatic or renal disease
- use of medications that would affect narcotic pharmacodynamics
- preoperative nausea, vomiting, or pruritis
- diagnosis of alcoholism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
|
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Other Names:
|
Active Comparator: B
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
|
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea Assessment by Patient
Time Frame: 1 hour after surgery, 8 hours after surgery
|
Nausea scale range: (0 = none, 10 = the worst), ordinal.
|
1 hour after surgery, 8 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
Time Frame: 1 hour after surgery, 8 hours after surgery
|
The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).
|
1 hour after surgery, 8 hours after surgery
|
Pain Assessment by Patient
Time Frame: 1 hour after surgery, 8 hours after surgery
|
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
|
1 hour after surgery, 8 hours after surgery
|
The Number of Patients Who Vomited
Time Frame: 1 hour after surgery, 8 hours after surgery
|
1 hour after surgery, 8 hours after surgery
|
|
Mean Score on the Ramsey Scale of Sedation
Time Frame: 1 hour after surgery, 8 hours after surgery
|
The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).
|
1 hour after surgery, 8 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2003
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 5, 2006
First Submitted That Met QC Criteria
October 5, 2006
First Posted (Estimate)
October 9, 2006
Study Record Updates
Last Update Posted (Actual)
August 14, 2018
Last Update Submitted That Met QC Criteria
July 16, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA2949
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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