Trial Outcomes & Findings for Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal (NCT NCT04112160)
NCT ID: NCT04112160
Last Updated: 2024-01-10
Results Overview
Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Seven days following ureteral stent removal.
Results posted on
2024-01-10
Participant Flow
Participant milestones
| Measure |
Control
normal saline 0.9%
normal saline: normal saline
|
Ketorolac
30 mg of Ketorolac
Ketorolac: IM injection of either normal saline or Ketorolac
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Baseline characteristics by cohort
| Measure |
Control
n=63 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
57 Years
n=5 Participants
|
54 Years
n=7 Participants
|
56 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
62 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Visual Analog Pain (VAS) Pain Scale at the baseline
|
1 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Seven days following ureteral stent removal.Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Number of Participants With Unscheduled Return to Clinic or Emergency Room
|
8 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Twenty-four hours following ureteral stent removal.Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
|
2 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Within thirty days post injection.Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Number of Participants That Experienced an Injection Complication
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Seven days following ureteral stent removal.Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
|
0 score on a scale (0-10, 0= no pain)
Interval 0.0 to 1.0
|
0 score on a scale (0-10, 0= no pain)
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Twenty-four hours following stent removal.Population: Number of patients that had any opioid use at 24 hours post stent removal.
Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Seven days following stent removal.Determine amount of missed work or school due to renal colic following ureteral stent removal.
Outcome measures
| Measure |
Control
n=62 Participants
normal saline 0.9%
|
Ketorolac
n=62 Participants
30 mg of Ketorolac
|
|---|---|---|
|
Average Number of Days the Participant Missed Work
|
2.3 days of missed work
Standard Deviation 3.7
|
2.7 days of missed work
Standard Deviation 4.2
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place