Lidocaine Analgesia for Urethral Catheterization in Children
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.
- To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.
To assess parental impression of discomfort between intervention and control groups.
- To assess pain associated with the administration of intraurethral 2% lidocaine jelly.
- 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 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|
- Pain Score on the Face, Legs, Arms, Cry, Consolability (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. Score range for the FLACC scale was between 0-10 where higher score is more pain.
|Study Start Date:||January 2013|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
No Intervention: No lidocaine
This group will have urinary catheterization without lidocaine (per standard procedure)
The Intervention is the application of intraurethral lidocaine 5 minutes prior to urethral catheterization.
Intervention - intraurethral lidocaine
Other Name: lidocaine gel
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01780324
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Neil Uspal, MD||Seattle Children's|