Lidocaine Lubricant in Pediatric Urethral Catheterization
Completed · Not applicable
Conditions studied: Fevers, Pain
In brief
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 setting.
Key facts
- Study ID
- NCT00596375
- Run by
- Children's Healthcare of Atlanta
- People needed
- 47
- Starts
- 2006-08-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2008-01-17
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Febrile patients aged 2 months to 2 years receiving urethral catheterization to obtain sterile urine for microbiologic and chemistry testing will be eligible to participate. Our study will be limited to children presenting with fever secondary to an unknown source, as ED triage protocol requires the administration of non-steroidal analgesic to treat fever.
You may not qualify if…
- The physician determines the patient is in need of immediate treatment or catheterization
- Patients have a history of genitourinary abnormalities
- Patients have had a previous catheterization
- Primary caregiver has limited English proficiency
- Patients with a history of genitourinary abnormalities
- Patients with history of prior catheterization are excluded from enrollment
Where it is running
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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