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Lidocaine Analgesia for Urethral Catheterization in Children

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ClinicalTrials.gov Identifier: NCT01780324
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Eileen Klein, Seattle Children's Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Pediatric Presentation of Urinary Tract Infection Drug: Lidocaine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eileen Klein, Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01780324     History of Changes
Other Study ID Numbers: 24080004
First Posted: January 31, 2013    Key Record Dates
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
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