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Lidocaine Analgesia for Urethral Catheterization in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eileen Klein, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01780324
First received: January 17, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Need for Urethral Catheterization to Rule Out Urinary Tract Infection.
Drug: Lidocaine gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 FLACC scale [ Time Frame: At time of procedure (up to 30 seconds after catheter insertion) ] [ Designated as safety issue: No ]
    Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups


Estimated Enrollment: 68
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
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
This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Drug: Lidocaine gel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01780324

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

No publications provided

Responsible Party: Eileen Klein, Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01780324     History of Changes
Other Study ID Numbers: 24080004
Study First Received: January 17, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014