A Randomized Control Trial Comparing Single vs. Multiple Application of Lidocaine Analgesia Prior… (NCT00142064) | Clinical Trial Compass
CompletedPhase 2
A Randomized Control Trial Comparing Single vs. Multiple Application of Lidocaine Analgesia Prior to Urethral Catheterization Procedures
United States200 participantsStarted 2005-08
Plain-language summary
The purpose of this study is to determine if a single application of Lidocaine gel topical anesthesia is as effective in decreasing the discomfort associated with urinary catheterization as two applications, within our pediatric population. Currently, two applications is our standard of care within our pediatric Radiology Department. Urinary catheterization is the process of placing a flexible tube into the urinary opening (urethra), to drain urine or instill radiographic solution for study of the anatomy and/or function of the urinary system. Members of the study team hypothesize equivalence in the observer reported catheterization pain scores as measured by the FLACC pain scale. The study is designed to obtain conclusive data to guide clinical practice.
The study team hypothesizes that statistically similar levels of analgesia will be observed with the single application procedure as compared to the multiple application technique.
Who can participate
Age range
2 Months – 7 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:
* Outpatient procedures only
* Voiding Cystourethrograms
* Nuclear Medicine Cystograms
* Nuclear Medicine Renal Mag 3 scans
* All of above require a urinary catheterization
Exclusion Criteria:
* Legal guardian(s) is/are not present for permission
* Patients with altered levels of pain perceptions (i.e. patients with Spina Bifida, prior known sexual abuse, prior urethral surgery or prior urethral trauma)
* Patients with a current or past history of consistent catheterization
* Patients who are/have been sedated or anesthetized
* Patients who are requiring urine testing other than routine urinalysis and/or culture, as per our present policy of the exclusion of Lidocaine pre-analgesia for other urine studies.
* Any infant or child with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
* Hematology/Oncology patients with neutropenia.
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
Cumulative pain score utilizing the FLACC pain scale(0-10), for pediatric patients age 2 months through 7 years of age.