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Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Primary Purpose

Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disorder of Urinary Stent focused on measuring ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liquid ibuprofen

Liquid placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Opioid Usage Post-operatively
This will be recorded in equivalents to milligrams intravenous morphine

Full Information

First Posted
May 14, 2014
Last Updated
March 29, 2021
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT02140970
Brief Title
Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Official Title
Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
January 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction, Urolithiasis
Keywords
ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liquid ibuprofen
Arm Type
Experimental
Arm Description
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Arm Title
Liquid placebo
Arm Type
Placebo Comparator
Arm Description
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Primary Outcome Measure Information:
Title
Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
Description
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
Secondary Outcome Measure Information:
Title
Incidence of "Significantly Worsening" Pain
Description
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
Title
Change in Pre- and Post-operative Pain Score
Description
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
Title
Opioid Usage Post-operatively
Description
This will be recorded in equivalents to milligrams intravenous morphine
Time Frame
24 hours after stent removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 4-17 unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Campbell, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22578110
Citation
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.
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Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

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