Status:
COMPLETED
A Randomized Control Trial Comparing Single vs. Multiple Application of Lidocaine Analgesia Prior to Urethral Catheterization Procedures
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Urinary Tract Infection
Kidney Diseases
Eligibility:
All Genders
2-7 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if a single application of Lidocaine gel topical anesthesia is as effective in decreasing the discomfort associated with urinary catheterization as two applic...
Detailed Description
This randomized control trial is designed to obtain conclusive data to guide clinical practice and will be a single site study. The study examines variations in observer reported catheterization pain ...
Eligibility Criteria
Inclusion
- Outpatient procedures only
- Voiding Cystourethrograms
- Nuclear Medicine Cystograms
- Nuclear Medicine Renal Mag 3 scans
- All of above require a urinary catheterization
Exclusion
- Legal guardian(s) is/are not present for permission
- Patients with altered levels of pain perceptions (i.e. patients with Spina Bifida, prior known sexual abuse, prior urethral surgery or prior urethral trauma)
- Patients with a current or past history of consistent catheterization
- Patients who are/have been sedated or anesthetized
- Patients who are requiring urine testing other than routine urinalysis and/or culture, as per our present policy of the exclusion of Lidocaine pre-analgesia for other urine studies.
- Any infant or child with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
- Hematology/Oncology patients with neutropenia.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00142064
Start Date
August 1 2005
End Date
April 1 2007
Last Update
April 18 2007
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108