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

NCT00142064 | Completed Phase 2 DMC

• 1 other identifier: 05 06-080
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Urinary Tract Infection; Kidney Diseases; Ureteral Diseases; Ureteral Obstruction

Keywords

Topical analgesia; Urinary catheterization; FlACC Pain Scale; Lidocaine jelly

Outcome Measures

Primary Outcomes (1)

• Cumulative pain score utilizing the FLACC pain scale(0-10), for pediatric patients age 2 months through 7 years of age.

Secondary Outcomes (11)

• Other data collected:

• patient age in years/months

• gender

• race/ethnicity

• patient heart rate pre-catheterization and at time of

Interventions

observed levels of pain BEHAVIORAL

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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
• Any infant or child with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
• Hematology/Oncology patients with neutropenia.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Kidney Diseases; Ureteral Diseases; Ureteral Obstruction

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Brenda K Boots, BSN

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: August 1, 2005
• Study Completion: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2006-09

Locations

US (1)