Trial Outcomes & Findings for Study of Ketorolac Versus Opioid for Pain After Endoscopy (NCT NCT03888144)

NCT ID: NCT03888144

Last Updated: 2025-12-23

Results Overview

Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 81 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2025-12-23

Participant Flow

Participant milestones

Measure	Ketorolac Group Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days	Oxycodone Group Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days
Overall Study STARTED	38	43
Overall Study COMPLETED	38	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Ketorolac Versus Opioid for Pain After Endoscopy

Baseline characteristics by cohort

Measure	Oxycodone Group n=43 Participants Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days	Ketorolac Group n=38 Participants Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=68 Participants	38 Participants n=4 Participants	81 Participants n=219 Participants
Age, Categorical >=65 years	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Age, Continuous	51.2 years STANDARD_DEVIATION 14.0 • n=68 Participants	53.8 years STANDARD_DEVIATION 12.4 • n=4 Participants	52.4 years STANDARD_DEVIATION 13.3 • n=219 Participants
Sex: Female, Male Female	24 Participants n=68 Participants	16 Participants n=4 Participants	40 Participants n=219 Participants
Sex: Female, Male Male	19 Participants n=68 Participants	22 Participants n=4 Participants	41 Participants n=219 Participants
Race/Ethnicity, Customized Caucasian	38 Participants n=68 Participants	33 Participants n=4 Participants	71 Participants n=219 Participants
Race/Ethnicity, Customized Non Caucasian	5 Participants n=68 Participants	5 Participants n=4 Participants	10 Participants n=219 Participants

PRIMARY outcome

Timeframe: 5 days

Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.

Outcome measures

Measure	Ketorolac Group n=38 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain	Oxycodone Group n=43 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain
Visual Analog Pain Score	4.5 units on a scale Standard Deviation 2.9	4.6 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Post-operative days 1 to 5

Population: 5 patients in the Oxy group and 2 in the Ketorolac group didn't require meds so they were excluded from final calculation

the use of opioid medication as per the study protocol; Required study pills

Outcome measures

Measure	Ketorolac Group n=36 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain	Oxycodone Group n=38 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain
Number of Study Pills Used	7.1 number of pills used Standard Deviation 5.2	7.3 number of pills used Standard Deviation 6.1

SECONDARY outcome

Timeframe: post operative day 1-5

Population: not all enrolled subjects used rescue medications

the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients

Outcome measures

Measure	Ketorolac Group n=11 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain	Oxycodone Group n=21 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain
Use of Rescue Medication (Opioid)	0.8 number of pills used Standard Deviation 1.2	1.1 number of pills used Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 days

number of days patient spent confined to bed post operatively

Outcome measures

Measure	Ketorolac Group n=38 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain	Oxycodone Group n=41 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain
Day in Bed	1 days Standard Deviation 1.3	2.3 days Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 days

VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain)

Outcome measures

Measure	Ketorolac Group n=38 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain	Oxycodone Group n=41 Participants Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain
Visual Analogue Scale (VAS)	4.5 units on a scale Standard Deviation 2.9	4.6 units on a scale Standard Deviation 3.1

Adverse Events

Oxycodone Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Ketorolac Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxycodone Group n=43 participants at risk Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days	Ketorolac Group n=38 participants at risk Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days
Gastrointestinal disorders nausea	27.9% 12/43 • Number of events 12 • the side effects have been reported over the study period of 2 years	28.9% 11/38 • Number of events 11 • the side effects have been reported over the study period of 2 years
Gastrointestinal disorders vomiting	7.0% 3/43 • Number of events 3 • the side effects have been reported over the study period of 2 years	2.6% 1/38 • Number of events 1 • the side effects have been reported over the study period of 2 years

Additional Information

Dr Sriharan Sivalingam

Cleveland Clinic foundation

Phone: 2162130159

Email: SIVALIS@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place