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

• Sponsor: Phoenix Children's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02483793
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 17.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorder of Urinary Stent	Drug: Tamsulosin; Drug: Oxybutynin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Discomfort in the Pediatric Population
• Study Start Date: Jul 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Phoenix Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phoenix Children's Hospital
• ClinicalTrials.gov Identifier: NCT02483793
• Other Study ID Numbers: 15-065
• First Posted: Jun 29, 2015
• Last Update Posted: Jun 29, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Tamsulosin; Oxybutynin

Study Results

No Results Posted as of Jun 29, 2015