Lidocaine Analgesia for Urethral Catheterization in Children

NCT01780324 | Completed Results

• 1 other identifier: 24080004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
2. 2.To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.
3. 3.To assess pain associated with the administration of intraurethral 2% lidocaine jelly.
4. 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.

Conditions

Pediatric Presentation of Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

No lidocaine

NO INTERVENTION

This group will have urinary catheterization without lidocaine (per standard procedure)

Lidocaine

EXPERIMENTAL

The Intervention is the application of intraurethral lidocaine 5 minutes prior to urethral catheterization.

Drug: Lidocaine

Interventions

Lidocaine DRUG

Intervention - intraurethral lidocaine

Also known as: lidocaine gel

Lidocaine

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Neil Uspal, MD
• Organization: Seattle Children's Hospital

neil.uspal@seattlechildrens.org

206-987-2599

Study Officials

• Neil Uspal, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)