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

Participant Flow

Recruitment Details	Patients were recruited from October 2008 to November 2010.
Pre-assignment Details


Arm/Group Title	Ketorolac	Placebo
Arm/Group Description	90 mg ketorolac in 1 L of normal sa...	1 L of normal saline infused at 40-...
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

Baseline Characteristics

Arm/Group Title		Ketorolac	Placebo	Total
Arm/Group Description		90 mg ketorolac in 1 L of normal sa...	1 L of normal saline infused at 40-...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Pain 'Right Now'
Description	Visual analog scale score for pain on a scale from 0 = None to 10 = Wo...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Ketorolac	Placebo
Arm/Group Description:	90 mg ketorolac in 1 L of normal sa...	1 L of normal saline infused at 40-...
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
Description	The morphine equivalent is a unit of measure to compare the efficacy o...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Ketorolac	Placebo
Arm/Group Description:	90 mg ketorolac in 1 L of normal sa...	1 L of normal saline infused at 40-...
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)

Adverse Events

Time Frame	Adverse events were noted during hospitalization (approximately 4 days).
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Ketorolac		Placebo
Arm/Group Description	90 mg ketorolac in 1 L of normal sa...		1 L of normal saline infused at 40-...
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	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Ketorolac		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0.00%)		0/54 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Mitchell R. Humphreys MD
Organization:	Mayo Clinic
Phone:	480-301-8000
EMail:	humphreys.mitchell@mayo.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grimsby GM, Andrews PE, Castle EP, Nunez R, Mihalik LA, Chang YH, Humphreys MR. Long-term renal function after donor nephrectomy: secondary follow-up analysis of the randomized trial of ketorolac vs placebo. Urology. 2014 Jul;84(1):78-81. doi: 10.1016/j.urology.2014.04.009.

Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8.

Layout table for additonal information

Responsible Party:	Mitchell R. Humphreys, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00765232
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

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