Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
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|ClinicalTrials.gov Identifier: NCT00385541|
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : August 31, 2010
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Pain||Drug: Morphine PCA Drug: Hydromorphone PCA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia|
|Actual Study Start Date :||November 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Active Comparator: A
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
Drug: Morphine PCA
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Active Comparator: B
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
Drug: Hydromorphone PCA
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Other Name: Dilaudid
- Nausea Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ]Nausea scale range: (0 = none, 10 = the worst), ordinal.
- 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).
- 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.
- The Number of Patients Who Vomited [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385541
|United States, New York|
|Columbia Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Pamela Flood, MD||Columbia University|