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Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

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ClinicalTrials.gov Identifier: NCT00765232
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nephrectomy
Laparoscopic Donor Nephrectomy
Interventions Drug: Ketorolac
Drug: Placebo
Enrollment 111
Recruitment Details Patients were recruited from October 2008 to November 2010.
Pre-assignment Details  
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 57 54
Completed 57 54
Not Completed 0 0
Arm/Group Title Ketorolac Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 57 54 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 54 participants 111 participants
43  (11) 43  (13) 43  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Female
23
  40.4%
33
  61.1%
56
  50.5%
Male
34
  59.6%
21
  38.9%
55
  49.5%
1.Primary Outcome
Title Pain 'Right Now'
Hide Description Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.
Time Frame 24 hours after the end of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (1.8) 3.1  (2.3)
2.Primary Outcome
Title Morphine Equivalents of Concomitant Pain Medication
Hide Description The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.
Time Frame 24 hours after the end of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: mg
65  (54) 69  (53)
Time Frame Adverse events were noted during hospitalization (approximately 4 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Ketorolac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/54 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketorolac Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/57 (96.49%)      53/54 (98.15%)    
Blood and lymphatic system disorders     
Thrombocytopenia * 1  12/57 (21.05%)  12 4/54 (7.41%)  4
Leukocytosis * 1  38/57 (66.67%)  38 34/54 (62.96%)  34
Monocytosis * 1  4/57 (7.02%)  4 2/54 (3.70%)  2
Lymphocytosis * 1  3/57 (5.26%)  3 4/54 (7.41%)  4
Monocytopenia * 1  8/57 (14.04%)  8 10/54 (18.52%)  10
Anaemia * 1  36/57 (63.16%)  36 37/54 (68.52%)  37
Lymphopenia * 1  20/57 (35.09%)  20 23/54 (42.59%)  23
Gastrointestinal disorders     
Vomiting * 1  4/57 (7.02%)  4 5/54 (9.26%)  5
Nausea * 1  14/57 (24.56%)  14 18/54 (33.33%)  18
Metabolism and nutrition disorders     
NPN Increased * 1  33/57 (57.89%)  33 26/54 (48.15%)  26
Hypokalaemia * 1  20/57 (35.09%)  20 18/54 (33.33%)  18
Hyperkalaemia * 1  3/57 (5.26%)  3 2/54 (3.70%)  2
Blood Urea Decreased * 1  4/57 (7.02%)  4 3/54 (5.56%)  3
Hyponatraemia * 1  10/57 (17.54%)  10 9/54 (16.67%)  9
Hypochloremia * 1  6/57 (10.53%)  6 7/54 (12.96%)  7
Respiratory, thoracic and mediastinal disorders     
Hypercapnia * 1  12/57 (21.05%)  12 3/54 (5.56%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHOART
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
Responsible Party: Mitchell R. Humphreys, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00765232     History of Changes
Other Study ID Numbers: 08-000747 LDN
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: November 18, 2011
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012