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NCT00596375 · ClinicalTrials.gov registry record · NA
Lidocaine Lubricant in Pediatric Urethral Catheterization
A NA study, sponsored by Children's Healthcare of Atlanta.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT00596375: Completed NA study, sponsored by Children's Healthcare of Atlanta.
NCT00596375 is a NA study that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00596375, a NA study, has completed, sponsored by Children's Healthcare of Atlanta.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
In Emergency Departments (ED) across the nation there is renewed interest in finding ways to alleviate the pain and discomfort associated with many of the procedures that children must undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate for children, physicians are urged to advocate for child-specific research in pain management and the effective use of pain medication to ensure compassionate and competent management of pain. (AAP Statement, 2001) Pediatric urethral catheterizations are one such procedure in which children experience significant pain.(11) In present care, children over 2 months of age do not routinely receive intervention for urethral catheterization related anxiety and pain, and, anecdotal reports suggest that most require physical restraint to complete the procedure. Lidocaine is an anesthetic agent that provides relief from pain during many commonly performed ED procedures. Intraurethral Lidocaine has been shown to decrease pain associated with urethral catheter placement in cystograms, however, Lidocaine is not routinely used for urethral catheterizations in the CHOA ED. This study aims to investigate the potential use of Lidocaine as an anesthetic agent during urethral catheterization of children. Recently, two specific studies were performed investigating the use of Lidocaine to decrease discomfort associated with urethral catheterization. Using the strengths of both previously published studies, our study will use Lidocaine both topically and instilled into the urethra. Investigators plan to perform a prospective three-arm double-blinded randomized clinical trial investigating the effectiveness of Lidocaine jelly as a analgesic when used as a lubricant for urinary catheterization. Investigators aim to demonstrate that Lidocaine used as a lubricant anesthetic for urethral catheterization will provide a safe, time-efficient, and relatively easy way to decrease pediatric pain in the emergency department
Interventions
- PROCEDURE Lubricant Instillation
- DRUG Lidocaine Lubricant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-03 |
| Phase | NA |
What the finished NCT00596375 record still lists
NCT00596375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Lubricant Instillation is the first listed.
NCT00596375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00596375 about?
NCT00596375 is a clinical study titled "Lidocaine Lubricant in Pediatric Urethral Catheterization". In Emergency Departments (ED) across the nation there is renewed interest in finding ways to alleviate the pain and discomfort associated with many of the procedures that children must undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate for children, physicia...
What is the current status of trial NCT00596375?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2006-08. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00596375?
The interventions under investigation include: Lubricant Instillation (PROCEDURE), Lidocaine Lubricant (DRUG).
Who is sponsoring clinical trial NCT00596375?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00596375's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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