Trial Outcomes & Findings for Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal (NCT NCT02140970)
NCT ID: NCT02140970
Last Updated: 2021-04-26
Results Overview
Two pain scales were used (Faces pain scale-revised \[FPS-R\] and visual analogue scale \[VAS\]) and converted to continuous value 0-10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
24 hours after stent removal
Results posted on
2021-04-26
Participant Flow
2 participants withdrew from the study prior to randomization.
Participant milestones
| Measure |
Liquid Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
Received Intervention
|
23
|
25
|
|
Overall Study
Analyzed
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Liquid Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Misplaced consent, subject withdrawn
|
1
|
0
|
|
Overall Study
Did not meet inclusion criteria
|
0
|
1
|
Baseline Characteristics
Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Baseline characteristics by cohort
| Measure |
Liquid Ibuprofen
n=22 Participants
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
n=22 Participants
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.5 years
n=5 Participants
|
12.2 years
n=7 Participants
|
11.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 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
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after stent removalTwo pain scales were used (Faces pain scale-revised \[FPS-R\] and visual analogue scale \[VAS\]) and converted to continuous value 0-10.
Outcome measures
| Measure |
Liquid Ibuprofen
n=22 Participants
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
n=22 Participants
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 hours after stent removalIncidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
Outcome measures
| Measure |
Liquid Ibuprofen
n=22 Participants
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
n=22 Participants
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Incidence of "Significantly Worsening" Pain
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 hours after stent removalPain will be assessed via a 10 point \[NAME OF SCALE\] scale. Possible scores range from 0 to 10, with higher scores indicating more severe pain and a worse outcome.
Outcome measures
| Measure |
Liquid Ibuprofen
n=22 Participants
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
n=22 Participants
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Change in Pre- and Post-operative Pain Score
|
0.4 score on a scale
Interval -3.9 to 8.0
|
0.2 score on a scale
Interval -4.0 to 4.3
|
SECONDARY outcome
Timeframe: 24 hours after stent removalThis will be recorded in equivalents to milligrams intravenous morphine
Outcome measures
| Measure |
Liquid Ibuprofen
n=22 Participants
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
|
Liquid Placebo
n=22 Participants
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
|
|---|---|---|
|
Opioid Usage Post-operatively
|
0.0 mg/kg
Interval 0.0 to 0.0
|
0.0 mg/kg
Interval 0.0 to 0.0
|
Adverse Events
Liquid Ibuprofen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liquid Placebo
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