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 |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
38
|
|
Overall Study
COMPLETED
|
43
|
38
|
|
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=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
81 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 14.0 • n=9 Participants
|
53.8 years
STANDARD_DEVIATION 12.4 • n=6 Participants
|
52.4 years
STANDARD_DEVIATION 13.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
40 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
41 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
71 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Non Caucasian
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 5 daysPatient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
Outcome measures
| 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
|
|---|---|---|
|
Visual Analog Pain Score
|
4.6 units on a scale
Standard Deviation 3.1
|
4.5 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Post-operative days 1 to 5Population: 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 |
Oxycodone Group
n=38 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=36 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
|
|---|---|---|
|
Number of Study Pills Used
|
7.3 number of pills used
Standard Deviation 6.1
|
7.1 number of pills used
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: post operative day 1-5Population: 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 |
Oxycodone Group
n=21 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=11 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
|
|---|---|---|
|
Use of Rescue Medication (Opioid)
|
1.1 number of pills used
Standard Deviation 1.3
|
0.8 number of pills used
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysnumber of days patient spent confined to bed post operatively
Outcome measures
| Measure |
Oxycodone Group
n=41 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
|
|---|---|---|
|
Day in Bed
|
2.3 days
Standard Deviation 2.6
|
1 days
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 daysVAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain)
Outcome measures
| Measure |
Oxycodone Group
n=41 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
|
|---|---|---|
|
Visual Analogue Scale (VAS)
|
4.6 units on a scale
Standard Deviation 3.1
|
4.5 units on a scale
Standard Deviation 2.9
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place