Kidney Diseases Clinical Trial
Official title:
A Randomized Control Trial Comparing Single to Multiple Application Lidocaine Analgesia Prior to Urethral Catheterization Procedures
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Months to 7 Years |
Eligibility |
Inclusion Criteria: - Outpatient procedures only - Voiding Cystourethrograms - Nuclear Medicine Cystograms - Nuclear Medicine Renal Mag 3 scans - All of above require a urinary catheterization Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative pain score utilizing the FLACC pain scale(0-10), for pediatric patients age 2 months through 7 years of age. | |||
Secondary | Other data collected: | |||
Secondary | patient age in years/months | |||
Secondary | gender | |||
Secondary | race/ethnicity | |||
Secondary | patient heart rate pre-catheterization and at time of | |||
Secondary | catheterization | |||
Secondary | type of procedure requiring catheterization | |||
Secondary | time of procedure | |||
Secondary | type of age-appropriate child life techniques used during | |||
Secondary | the procedure | |||
Secondary | parental survey |
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