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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00142064
First received: August 31, 2005
Last updated: April 16, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Kidney Diseases
Ureteral Diseases
Ureteral Obstruction
Behavioral: observed levels of pain
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Control Trial Comparing Single to Multiple Application Lidocaine Analgesia Prior to Urethral Catheterization Procedures

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

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

Secondary Outcome Measures:
  • Other data collected:
  • patient age in years/months
  • gender
  • race/ethnicity
  • patient heart rate pre-catheterization and at time of
  • catheterization
  • type of procedure requiring catheterization
  • time of procedure
  • type of age-appropriate child life techniques used during
  • the procedure
  • parental survey

Estimated Enrollment: 200
Study Start Date: August 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   2 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142064

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Brenda K Boots, BSN Children's Mercy Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142064     History of Changes
Other Study ID Numbers: 05 06-080
Study First Received: August 31, 2005
Last Updated: April 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Topical analgesia
Urinary catheterization
FlACC Pain Scale
Lidocaine jelly

Additional relevant MeSH terms:
Kidney Diseases
Ureteral Diseases
Ureteral Obstruction
Urinary Tract Infections
Urologic Diseases
Infection
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014