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

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.

Study Overview

• Status: Unknown
• Conditions: Disorder of Urinary Stent
• Intervention / Treatment: Drug: Tamsulosin; Drug: Oxybutynin

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Nguyen, MD; Phone Number: (602) 933-5200; Email: mtn1023@hotmail.com
• Study Contact Backup: Name: Catherine Chen, MD; Phone Number: (602) 933-5200; Email: catherine.j.chen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxybutynin group; 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.	Drug: Oxybutynin
Active Comparator: Tamsulosin group; 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.	Drug: Tamsulosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 26, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Oxybutynin; Tamsulosin
• Other Study ID Numbers: 15-065