Trial Outcomes & Findings for Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy (NCT NCT00765128)

NCT ID: NCT00765128

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

17 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	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=8 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=9 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=17 Participants Total of all reporting groups
Age Continuous	59.0 years STANDARD_DEVIATION 8.0 • n=5 Participants	62.0 years STANDARD_DEVIATION 9.8 • n=7 Participants	60.6 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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=8 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=9 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'	1.0 units on a scale Standard Deviation 1.2	0.9 units on a scale Standard Deviation 1.5

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=8 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=9 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	15 mg Standard Deviation 33	10 mg Standard Deviation 14

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 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=8 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=9 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.
Blood and lymphatic system disorders Anaemia	87.5% 7/8 • Number of events 7 • Adverse events were noted during hospitalization (approximately 4 days).	22.2% 2/9 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hypochloraemia	25.0% 2/8 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).	0.00% 0/9 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Thrombocytopenia	37.5% 3/8 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).	22.2% 2/9 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hyponatraemia	37.5% 3/8 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).	22.2% 2/9 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hypokalaemia	25.0% 2/8 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Blood Urea Nitrogen Increased	25.0% 2/8 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Nonprotein Nitrogen Increased	12.5% 1/8 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).	0.00% 0/9 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Leucopenia	12.5% 1/8 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).	0.00% 0/9 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Leukocytosis	50.0% 4/8 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).	44.4% 4/9 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Monocytopenia	25.0% 2/8 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).	33.3% 3/9 • Number of events 3 • Adverse events were noted during hospitalization (approximately 4 days).
Metabolism and nutrition disorders Hyperchloraemia	12.5% 1/8 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).	22.2% 2/9 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Lymphadenopathy Cervical	0.00% 0/8 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/8 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Respiratory, thoracic and mediastinal disorders Hypocapnia	0.00% 0/8 • Adverse events were noted during hospitalization (approximately 4 days).	11.1% 1/9 • Number of events 1 • Adverse events were noted during hospitalization (approximately 4 days).
Blood and lymphatic system disorders Lymphopenia	25.0% 2/8 • Number of events 2 • Adverse events were noted during hospitalization (approximately 4 days).	44.4% 4/9 • Number of events 4 • Adverse events were noted during hospitalization (approximately 4 days).