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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 is a NA study that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 47 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00596375
The ClinicalTrials.gov registry entry for NCT00596375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Healthcare of Atlanta, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lubricant Instillation is the first listed.
NCT00596375 reports 0 study locations.
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.
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