Lidocaine Analgesia for Urethral Catheterization in Children (NCT01780324) | Clinical Trial Compass
CompletedNot Applicable
Lidocaine Analgesia for Urethral Catheterization in Children
United States80 participantsStarted 2013-01
Plain-language 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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale
Timeframe: At time of procedure (up to 30 seconds after catheter insertion)