Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
|ClinicalTrials.gov Identifier: NCT00385541|
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : August 31, 2010
Last Update Posted : March 20, 2015
|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|
|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).
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|