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

Phoenix Children's Hospital

Status: Withdrawn

Conditions: Disorder of Urinary Stent

Treatments: Drug: Oxybutynin; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT02483793

15-065

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

0 participants in 2 patient groups

Oxybutynin group

Active Comparator group

Description:

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.

Treatment:

Drug: Oxybutynin

Tamsulosin group

Active Comparator group

Description:

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.

Treatment:

Drug: Tamsulosin