Lidocaine Analgesia for Urethral Catheterization in Children

Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Presentation of Urinary Tract Infection
• Intervention / Treatment: Drug: Lidocaine

Detailed Description

Purpose: To determine whether use of transurethral lidocaine prior to transurethral catheterization for sterile urine collection decreases procedural pain in children 0-3 years old. 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.

Rationale: Urinary tract infections (UTIs) are the leading cause of serious bacterial infection in young infants and children. Diagnosis of a UTI in patients in this age group generally requires obtaining a urine sample via transurethral bladder catheterization (TUBC). TUBC is painful, yet standard practice does not include analgesia for infants and children in need of this procedure.

Lidocaine is a commonly used topical anesthetic. Lidocaine jelly can be administered into the urethra prior to catheterization, typically via a preloaded syringe (eg,Uro-Jet) and is FDA approved for this indication. Lidocaine jelly has no antimicrobial characteristics and is a sterile preparation, such that it will not alter urine culture results.

This study is a randomized clinical trial to compare the effectiveness of local 2% lidocaine analgesia instilled in the urethra to reduce the pain and distress in children less than 3 years requiring TUBC.

Reducing the pain and distress associated with TUBC is an important treatment goal, yet there is limited research in children on the effect of intraurethral analgesia during TUBC.

There is growing evidence that children who receive inadequate pain control during invasive procedures may suffer long-term effects.

This Randomized Clinical Trial (RCT) could provide the evidence to drive a change in practice for infants and children requiring bladder catheterization, reducing pain and distress for children undergoing this procedure.

Study Design: This study will enroll 68 children over approximately 1 year. Inclusion criteria includes age 0-3 years, an English or Spanish speaking guardian present to provide consent, and a medical indication for TUBC during the patient's emergency department (ED) visit. Exclusion criteria includes severe developmental delay or impaired mentation; a neural tube defect, paraplegia, or other condition altering urethral sensation; a known urethral stricture, anatomic abnormality or reconstruction; a history of sexual abuse; patient weight less than 2.3 kg; allergy or previous adverse reaction to lidocaine; previous enrollment in the study; or prior successful or attempted TUBC in previous 7 days Subjects will be randomized to receive either usual care for TUBC or 2% lidocaine jelly administered intraurethrally approximately 5 minutes prior to TUBC. Group assignment will be block randomized and stratified by gender. In the lidocaine group, 2% lidocaine would be administered intraurethrally via a blunt tipped Uro-Jet® 5 minutes before TUBC. Lidocaine would not be administered to the usual care group. Both lidocaine administration (if applicable) and TUBC will be videotaped. Research team members will gather information on parental impression of discomfort and patient medical history as well as any adverse events.

A trained, blinded observer will review videotaped procedures and assign pain scores using the Faces, Legs, Activity, Cry and Consolability (FLACC) scale. The FLACC scale is a validated pain scale utilized in pre-verbal children, which assesses pain in 5 separate behaviors during a procedure. For TUBC, pain scores will be recorded at baseline, during catheterization, and one minute after. After assigning FLACC scores, the research team member will then review each video again and assign MBPS scores. MBPS pain scores will be recorded at baseline, during catheterization, and one minute after. Following scoring of the TUBC procedure, patients in the intervention study arm will also have FLACC pain scores assigned one minute before, during, and one minute after administration of lidocaine.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: lidocaine gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale	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.	At time of procedure (up to 30 seconds after catheter insertion)

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Neil Uspal, MD, Seattle Children's

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 24080004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO