Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
This study has been completed.
Sponsor:
Columbia University
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00385541
First received: October 5, 2006
Last updated: January 12, 2011
Last verified: January 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | October 5, 2006 | ||||
| Last Updated Date | January 12, 2011 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Nausea Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ] Nausea scale range: (0 = none, 10 = the worst), ordinal. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00385541 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA) | ||||
| Official Title ICMJE | The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia | ||||
| Brief Summary | Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at our institution that hydromorphone causes less side effects but this has not been studied. We propose to treat our patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug |
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| Detailed Description | Patients having general surgery at Columbia University Medical Center that will require Patient-Controlled Analgesia Inclusion: 18-60. American Society of Anesthesiologists (ASA) 1-2 Exclusion, pregnancy, lactation, chronic pain or opioids prior to surgery |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Post Operative Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00385541 | ||||
| Other Study ID Numbers ICMJE | AAAA2949(Y3M01) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pamela Flood MD, Columbia University | ||||
| Study Sponsor ICMJE | Columbia University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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