A Randomized Control Trial Comparing Single vs. Multiple Application of Lidocaine Analgesia Prior to Urethral Catheterization Procedures
Condition: Urinary Tract Infection; Kidney Diseases; Ureteral Diseases; Ureteral Obstruction
MeSH terms: Urinary Tract Infections; Kidney Diseases; Ureteral Obstruction; Ureteral Diseases
Study type: Interventional
Phase: Phase 2

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 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.
    

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 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.
    

Intervention name(s): observed levels of pain
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Topical analgesia; Urinary catheterization; FlACC Pain Scale; Lidocaine jelly