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.
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 levels when pre-treatment occurs through either a single
application technique or a double application strategy.
Two treatment groups have been established for this investigation with individual assignment
into either of the two cohorts occurring through randomization. These two intervention
groups include (1) usual care with two applications (the control group) and (2) single
application (study group).
Those patients randomized to the control group will receive one application of gel
externally and one internal application of Lidocaine gel internally into the urethra, five
minutes apart. The final application occurs five minutes prior to catheterization. The
second group of patients is randomized to a pre-catheterization analgesia strategy that uses
one internal application five minutes prior to catheterization.
400 patients from two months through 7 years of age will be invited to participate in the
study. The primary outcome variable will be the cumulative FLACC pain score. The FLACC pain
scale is a simple graph for scoring the distress behavior or observed pain responses in
children who may not be able to rate the presence or severity of pain. One consistent
observer will be utilized to provide the scoring of this pain scale, and will remained
blinded to the method of Lidocaine application to which the child is randomized. A Child
Life Specialist will be responsible for offering age-appropriate diversion and comfort
techniques during the procedure. A parental survey will be completed by the parent(s) at
the conclusion of the study, to be collected in a locked survey box.
- Outpatient procedures only
- Voiding Cystourethrograms
- Nuclear Medicine Cystograms
- Nuclear Medicine Renal Mag 3 scans
- All of above require a urinary catheterization
- 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.