Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00765232
First received: September 30, 2008
Last updated: December 21, 2011
Last verified: December 2011
Results First Received: November 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Nephrectomy
Laparoscopic Donor Nephrectomy
Interventions: Drug: Ketorolac
Drug: Placebo

  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
Patients were recruited from October 2008 to November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketorolac 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Placebo 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Participant Flow:   Overall Study
    Ketorolac     Placebo  
STARTED     57     54  
COMPLETED     57     54  
NOT COMPLETED     0     0  



  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
Ketorolac 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Placebo 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Total Total of all reporting groups

Baseline Measures
    Ketorolac     Placebo     Total  
Number of Participants  
[units: participants]
  57     54     111  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 11     43  ± 13     43  ± 12  
Gender  
[units: participants]
     
Female     23     33     56  
Male     34     21     55  



  Outcome Measures
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1.  Primary:   Pain 'Right Now'   [ Time Frame: 24 hours after the end of surgery ]

2.  Primary:   Morphine Equivalents of Concomitant Pain Medication   [ Time Frame: 24 hours after the end of 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mitchell R. Humphreys MD
Organization: Mayo Clinic
phone: 480-301-8000
e-mail: humphreys.mitchell@mayo.edu


No publications provided by Mayo Clinic

Publications automatically indexed to this study:

Responsible Party: Mitchell R. Humphreys, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00765232     History of Changes
Other Study ID Numbers: 08-000747 LDN
Study First Received: September 30, 2008
Results First Received: November 18, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board