Trial Outcomes & Findings for Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy (NCT NCT00765232)

NCT ID: NCT00765232

Last Updated: 2012-01-27

Results Overview

Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

111 participants

Primary outcome timeframe

24 hours after the end of surgery

Results posted on

2012-01-27

Participant Flow

Patients were recruited from October 2008 to November 2010.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	57	54
Overall Study COMPLETED	57	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=57 Participants 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 n=54 Participants 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 n=111 Participants Total of all reporting groups
Age Continuous	43 years STANDARD_DEVIATION 11 • n=5 Participants	43 years STANDARD_DEVIATION 13 • n=7 Participants	43 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	21 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after the end of surgery

Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.

Outcome measures

Outcome measures
Measure	Ketorolac n=57 Participants 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 n=54 Participants 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.
Pain 'Right Now'	2.4 units on a scale Standard Deviation 1.8	3.1 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 24 hours after the end of surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=57 Participants 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 n=54 Participants 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.
Morphine Equivalents of Concomitant Pain Medication	65 mg Standard Deviation 54	69 mg Standard Deviation 53

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mitchell R. Humphreys MD

Mayo Clinic

Phone: 480-301-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ketorolac n=57 participants at risk 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 n=54 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hypercapnia	21.1% 12/57 • Number of events 12 • Adverse events were noted during hospitalization (approximately 4 days).	5.6% 3/54 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Thrombocytopenia	21.1% 12/57 • Number of events 12 • Adverse events were noted during hospitalization (approximately 4 days).	7.4% 4/54 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders NPN Increased	57.9% 33/57 • Number of events 33 • Adverse events were noted during hospitalization (approximately 4 days).	48.1% 26/54 • Number of events 26 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Leukocytosis	66.7% 38/57 • Number of events 38 • Adverse events were noted during hospitalization (approximately 4 days).	63.0% 34/54 • Number of events 34 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Monocytosis	7.0% 4/57 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).	3.7% 2/54 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hypokalaemia	35.1% 20/57 • Number of events 20 • Adverse events were noted during hospitalization (approximately 4 days).	33.3% 18/54 • Number of events 18 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hyperkalaemia	5.3% 3/57 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).	3.7% 2/54 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Blood Urea Decreased	7.0% 4/57 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).	5.6% 3/54 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hyponatraemia	17.5% 10/57 • Number of events 10 • Adverse events were noted during hospitalization (approximately 4 days).	16.7% 9/54 • Number of events 9 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Lymphocytosis	5.3% 3/57 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).	7.4% 4/54 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).
Gastrointestinal disorders Vomiting	7.0% 4/57 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).	9.3% 5/54 • Number of events 5 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hypochloremia	10.5% 6/57 • Number of events 6 • Adverse events were noted during hospitalization (approximately 4 days).	13.0% 7/54 • Number of events 7 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Monocytopenia	14.0% 8/57 • Number of events 8 • Adverse events were noted during hospitalization (approximately 4 days).	18.5% 10/54 • Number of events 10 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Anaemia	63.2% 36/57 • Number of events 36 • Adverse events were noted during hospitalization (approximately 4 days).	68.5% 37/54 • Number of events 37 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Lymphopenia	35.1% 20/57 • Number of events 20 • Adverse events were noted during hospitalization (approximately 4 days).	42.6% 23/54 • Number of events 23 • Adverse events were noted during hospitalization (approximately 4 days).
Gastrointestinal disorders Nausea	24.6% 14/57 • Number of events 14 • Adverse events were noted during hospitalization (approximately 4 days).	33.3% 18/54 • Number of events 18 • Adverse events were noted during hospitalization (approximately 4 days).