NCT02140970

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 26, 2021

Completed
Last Updated

April 26, 2021

Status Verified

March 1, 2021

Enrollment Period

5.7 years

First QC Date

May 14, 2014

Results QC Date

March 29, 2021

Last Update Submit

March 29, 2021

Conditions

Disorder of Urinary StentUreteral SpasmUreteropelvic Junction ObstructionUrolithiasis

Keywords

ureteral stentstent painureteral spasmNSAIDibuprofenplaceboureteropelvic junction obstructionurolithiasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours after stent removal

Secondary Outcomes (3)

  • Incidence of "Significantly Worsening" Pain

    24 hours after stent removal

  • Change in Pre- and Post-operative Pain Score

    24 hours after stent removal

  • Opioid Usage Post-operatively

    24 hours after stent removal

Study Arms (2)

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

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

Drug: Placebo

Interventions

IbuprofenDRUG

10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal

Liquid ibuprofen
PlaceboDRUG

Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal

Liquid placebo

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ages 4-17
  • unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis

You may not qualify if:

  • 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
  • chronic kidney disease
  • prior renal transplant
  • history of nasal polyps
  • history of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 22578110BACKGROUND

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateralUrolithiasis

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Kyle Rove
Organization
University of Colorado
kyle.rove@childrenscolorado.org
720 777 5893

Study Officials

  • Jeffrey Campbell, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

May 1, 2014

Primary Completion

January 11, 2020

Study Completion

January 11, 2020

Last Updated

April 26, 2021

Results First Posted

April 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)