Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00385541
First received: October 5, 2006
Last updated: January 12, 2011
Last verified: January 2011
Results First Received: July 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Post Operative Pain
Interventions: Drug: Morphine PCA
Drug: Hydromorphone PCA

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.

Reporting Groups
  Description
Morphine PCA Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
Hydromorphone PCA Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes

Participant Flow:   Overall Study
    Morphine PCA     Hydromorphone PCA  
STARTED     25     25  
COMPLETED     25     24  
NOT COMPLETED     0     1  
severe pain, clinician requested unblind                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Morphine PCA Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
Hydromorphone PCA Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Total Total of all reporting groups

Baseline Measures
    Morphine PCA     Hydromorphone PCA     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     25     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 12     44  ± 8     42.6  ± 10  
Gender  
[units: participants]
     
Female     23     22     45  
Male     2     3     5  
Region of Enrollment  
[units: participants]
     
United States     25     25     50  



  Outcome Measures
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1.  Primary:   Nausea Assessment by Patient   [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

2.  Secondary:   Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale   [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

3.  Secondary:   Pain Assessment by Patient   [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

4.  Secondary:   The Number of Patients Who Vomited   [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

5.  Secondary:   Mean Score on the Ramsey Scale of Sedation   [ Time Frame: 1 hour after surgery, 8 hours after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a small study under typical clinical conditions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pamela Flood MD
Organization: Columbia University
phone: 201-768-8262
e-mail: pdf3@columbia.edu


Publications of Results:

Responsible Party: Pamela Flood MD, Columbia University
ClinicalTrials.gov Identifier: NCT00385541     History of Changes
Other Study ID Numbers: AAAA2949(Y3M01)
Study First Received: October 5, 2006
Results First Received: July 14, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board