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

Disorder of Urinary Stent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02483793
• Other study ID #: 15-065
• Status: Not yet recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 26, 2015
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Phoenix Children's Hospital
• Contact: Michael Nguyen, MD
• Phone: (602) 933-5200
• Email: mtn1023[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Urinary Stent

Intervention

Drug:
• Tamsulosin

• Oxybutynin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No