Lidocaine Analgesia for Urethral Catheterization in Children
|ClinicalTrials.gov Identifier: NCT01780324|
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
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.
|Condition or disease||Intervention/treatment|
|Pediatric Presentation of Urinary Tract Infection||Drug: Lidocaine|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children|
|Study Start Date :||January 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2015|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780324
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Neil Uspal, MD||Seattle Children's|