An interventional study of Ibuprofen and Placebo in Disorder of Urinary Stent, Ureteral Spasm and Ureteropelvic Junction Obstruction, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
This study plans to learn more about whether ibuprofen can reduce pain after removal of a ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral stent. The investigators plan to learn how often this occurs and whether it can be prevented.
The investigators hypothesize that children who have a temporary, indwelling ureteral stent will experience a significantly less post-operative pain if given a non-steroidal anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo. The investigators hypothesize that the incidence of severe post-stent removal pain is similar to an adult population.
26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.
This study's enrollment of 51 is above the median of 40 across 20 interventional studies indexed under Multicystic renal dysplasia, bilateral.
Browse Multicystic renal dysplasia, bilateral studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Drug: Ibuprofen
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Drug: Placebo
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
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)
Two pain scales were used (Faces pain scale-revised \[FPS-R\] and visual analogue scale \[VAS\]) and converted to continuous value 0-10.
Time frame: 24 hours after stent removal
Incidence of "Significantly Worsening" Pain
Incidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
Time frame: 24 hours after stent removal
Change in Pre- and Post-operative Pain Score
Pain 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.
Time frame: 24 hours after stent removal
Opioid Usage Post-operatively
This will be recorded in equivalents to milligrams intravenous morphine
Time frame: 24 hours after stent removal
| Milestone | Liquid Ibuprofen | Liquid Placebo |
|---|---|---|
| Started | 24 | 25 |
| Received intervention | 23 | 25 |
| Analyzed | 22 | 22 |
| Completed | 22 | 22 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Misplaced consent, subject withdrawn | 1 | 0 |
| Withdrew: Did not meet inclusion criteria | 0 | 1 |
Two pain scales were used (Faces pain scale-revised \[FPS-R\] and visual analogue scale \[VAS\]) and converted to continuous value 0-10.
| Participants | Liquid Ibuprofen | Liquid Placebo |
|---|---|---|
| Incidence of Post-operative Severe Pain (Pain Score ≥ 7) | 2 | 1 |
Incidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
| Participants | Liquid Ibuprofen | Liquid Placebo |
|---|---|---|
| Incidence of "Significantly Worsening" Pain | 3 | 5 |
Pain 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.
| score on a scale | Liquid Ibuprofen | Liquid Placebo |
|---|---|---|
| Change in Pre- and Post-operative Pain Score | 0.4 (-3.9 to 8) | 0.2 (-4.0 to 4.3) |
This will be recorded in equivalents to milligrams intravenous morphine
| mg/kg | Liquid Ibuprofen | Liquid Placebo |
|---|---|---|
| Opioid Usage Post-operatively | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
Collected over Adverse event data were collected 30 days after exposure to the intervention.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liquid Ibuprofen | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Liquid Placebo | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
Only participants who were analyzed are included.
| Age, Categorical(Participants) | Liquid Ibuprofen | Liquid Placebo | Total |
|---|---|---|---|
| <=18 years | 22 | 22 | 44 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Liquid Ibuprofen | Liquid Placebo | Total |
|---|---|---|---|
| Mean | 10.5 (4.2 to 17.3) | 12.2 (4.7 to 18.0) | 11.4 (4.2 to 18.0) |
| Sex: Female, Male(Participants) | Liquid Ibuprofen | Liquid Placebo | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 12 | 11 | 23 |
| Race (NIH/OMB)(Participants) | Liquid Ibuprofen | Liquid Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 21 | 21 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liquid Ibuprofen | Liquid Placebo | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of May 2014, a primary completion of Jan 2020 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2021, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ibuprofen
Multicystic renal dysplasia, bilateral →
University of Colorado, Denver →