Disorder of Urinary StentNCT02140970
Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
A study testing Ibuprofen in people with Disorder of Urinary Stent and Ureteral Spasm, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 11 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 4-17
- unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
Who cannot join
- bilateral stents
- undergoing other concomitant procedure at time of planned ureteral stent removal
- indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
- pregnant
- developmental delay
- allergy to ibuprofen or non-steroidal anti-inflammatory medication class
Show all 10Show fewer
- chronic kidney disease
- prior renal transplant
- history of nasal polyps
- history of asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
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.
- Conditions
- Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction, Urolithiasis
- Being tested
- Ibuprofen, Placebo
- Keywords
- ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
PlaceboDrug
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
| Study group | Role | What they receive |
|---|---|---|
| Liquid ibuprofen | Experimental | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal Receives: Drug: Ibuprofen |
| Liquid placebo | Placebo comparator | Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after stent removal
Secondary outcomes (3)
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
Measured: 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.
Measured: 24 hours after stent removal
Opioid Usage Post-operatively
This will be recorded in equivalents to milligrams intravenous morphine
Measured: 24 hours after stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Urinary StentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Jeffrey Campbell, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140970
- Sponsor's protocol ID
- 14-0514
- Status last verified
- Mar 2021
- First submitted
- 14 May 2014
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tadros NN, Bland L, Legg E, Olyaei A, Conlin MJ. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int. 2013 Jan;111(1):101-5. doi: 10.1111/j.1464-410X.2012.11214.x. Epub 2012 May 11.
PubMed 22578110
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
- ClinicalTrials.gov ID
- NCT02140970
- Acronym / sponsor ID
- 14-0514
- Conditions
- Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction, Urolithiasis
- Keywords
- ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- May 2014
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid ibuprofen | Experimental | Drug: Ibuprofen10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
| Liquid placebo | Placebo comparator | Drug: PlaceboSimilar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ages 4-17
- unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
Key exclusion criteria (10 listed)
- bilateral stents
- undergoing other concomitant procedure at time of planned ureteral stent removal
- indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
- pregnant
- developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal | Drug | Liquid ibuprofen |
| PlaceboSimilar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal | Drug | Liquid placebo |
Primary outcome
Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
Time frame: 24 hours after stent removal
Two pain scales were used (Faces pain scale-revised [FPS-R] and visual analogue scale [VAS]) and converted to continuous value 0-10.
3 secondary outcomes
Incidence of "Significantly Worsening" Pain
Time frame: 24 hours after stent removal
Change in Pre- and Post-operative Pain Score
Time frame: 24 hours after stent removal
Opioid Usage Post-operatively
Time frame: 24 hours after stent removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22578110Tadros NN, Bland L, Legg E, Olyaei A, Conlin MJ. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int. 2013 Jan;111(1):101-5. doi: 10.1111/j.1464-410X.2012.11214.x. Epub 2012 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Campbell, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Disorder of Urinary Stent and Ureteral Spasm, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-operative Severe Pain (Pain Score ≥ 7) (time frame: 24 hours after stent removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.