N/A N=80 Randomized Single-blind Treatment

Lidocaine Analgesia for Urethral Catheterization in Children

Pediatric Presentation of Urinary Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT01780324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale — 9; 8 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lidocaine (Drug)
Age: Pediatric
Sex: All
Sponsor: Seattle Children's Hospital
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale	9; 8	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01780324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.