A Randomized Control Trial Comparing Single vs. Multiple Application of Lidocaine Analgesia Prior to Urethral Catheterization Procedures

Completed · Phase 2

Conditions studied: Urinary Tract Infection, Kidney Diseases, Ureteral Diseases, Ureteral Obstruction

In brief

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 applications, within our pediatric population. Currently, two applications is our standard of care within our pediatric Radiology Department. Urinary catheterization is the process of placing a flexible tube into the urinary opening (urethra), to drain urine or instill radiographic solution for study of the anatomy and/or function of the urinary system. Members of the study team hypothesize equivalence in the observer reported catheterization pain scores as measured by the FLACC pain scale. The study is designed to obtain conclusive data to guide clinical practice. The study team hypothesizes that statistically similar levels of analgesia will be observed with the single application procedure as compared to the multiple application technique.

Key facts

Study ID

NCT00142064

Run by

Children's Mercy Hospital Kansas City

People needed

200

Starts

2005-08-01

Expected to finish

2007-04-01

Last updated by the study team

2007-04-18

Who can join

Age: 0 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Outpatient procedures only
• Voiding Cystourethrograms
• Nuclear Medicine Cystograms
• Nuclear Medicine Renal Mag 3 scans
• All of above require a urinary catheterization

You may not qualify if…

• 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.

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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