Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population

Not Applicable

• Conditions: Disorder of Urinary Stent
• Interventions: Drug: Oxybutynin; Drug: Tamsulosin

• Registration Number: NCT02483793
• Lead Sponsor: Phoenix Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-26
• Last Update Submitted: 2015-06-26
• Study First Posted: 2015-06-29
• Last Update Posted: 2015-06-29
• Study Start: 2015-07
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

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Exclusion Criteria

• Patients with developmental delay or unable to verbalize their pain level will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxybutynin group	Oxybutynin	This 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	Tamsulosin	This 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.

Primary Outcome Measures

Name	Time	Method
Pain scale based on the faces pain score	5 days post-op	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.
Number of doses of pain in medication used	5 days post-op	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.