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Lidocaine Analgesia for Urethral Catheterization in Children

This study has been completed.
Information provided by (Responsible Party):
Eileen Klein, Seattle Children's Hospital Identifier:
First received: January 17, 2013
Last updated: March 28, 2016
Last verified: March 2016

Primary Aim

1. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Secondary Aims

  1. To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
  2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.

    To assess parental impression of discomfort between intervention and control groups.

  3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.
  4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.

Condition Intervention
Pediatric Presentation of Urinary Tract Infection
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children

Resource links provided by NLM:

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale [ Time Frame: At time of procedure (up to 30 seconds after catheter insertion) ]
    Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: May 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No lidocaine
This group will have urinary catheterization without lidocaine (per standard procedure)
Experimental: Lidocaine
The Intervention is the application of intraurethral lidocaine 5 minutes prior to urethral catheterization.
Drug: Lidocaine
Intervention - intraurethral lidocaine
Other Name: lidocaine gel

  Show Detailed Description


Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 0-3 years
  • English or Spanish speaking
  • Legal guardian present to provide consent
  • Medical indication for TUBC during the patient's ED visit

Exclusion Criteria:

  • Severe developmental delay or impaired mentation
  • Neural tube defect, paraplegia, or other condition altering urethral sensation
  • Known urethral stricture, anatomic abnormality or reconstruction
  • History of sexual abuse
  • Patient weight less than 2.3 kg
  • Allergy or previous adverse reaction to lidocaine
  • Previous enrollment in the study
  • Prior successful or attempted TUBC in previous 7 days
  Contacts and Locations
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Please refer to this study by its identifier: NCT01780324

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Neil Uspal, MD Seattle Children's
  More Information

Responsible Party: Eileen Klein, Investigator, Seattle Children's Hospital Identifier: NCT01780324     History of Changes
Other Study ID Numbers: 24080004
Study First Received: January 17, 2013
Results First Received: November 25, 2015
Last Updated: March 28, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017