Study Stopped
The study was withdrawn prior to IRB approval and prior to enrollment. The study was never opened, and no participants were enrolled.
Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population
Randomized Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Discomfort in the Pediatric Population
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety tamsulosin in reducing stent discomfort in the pediatric population in the peri-operative period. The secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in reducing stent discomfort.
Trial Health
Trial Health Score
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Started Jul 2015
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 29, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 14, 2026
June 1, 2015
1.4 years
June 22, 2015
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of doses of pain in medication used
After surgery, each child will be prescribed the standard dosage of oxycodone/acetaminophen based on their weight. We will have the patient's family record the number of doses of narcotics used from post-operative day #1 to post-operative day #5 to assess their pain needs.
5 days post-op
Pain scale based on the faces pain score
We will have the family members record the child's pain score in the morning and evening using the faces pain scale and record the score.
5 days post-op
Study Arms (2)
Oxybutynin group
ACTIVE COMPARATORThis group will be prescribed oxybutynin as well as standard narcotic pain medications. Oxybutynin will be prescribed based off of standard dosing. Patients who are unable to swallow pills will be given oxybutynin elixir (0.5mg/kg/day, divided TID). Patients who are able to swallow pills will be given oxybutynin 5mg either BID or TID.
Tamsulosin group
ACTIVE COMPARATORThis group will be prescribed tamsulosin and standard narcotic pain medication. Patients will be given tamsulosin 0.4mg at bedtime. This dosage has been used in other studies for children age ≥ 4.
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 4-18 years will be enrolled in this study. We will include all patients who will have a ureteral stent placement after their procedure.
You may not qualify if:
- Patients with developmental delay or unable to verbalize their pain level will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 29, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 14, 2026
Record last verified: 2015-06