Lidocaine Lubricant in Pediatric Urethral Catheterization
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|ClinicalTrials.gov Identifier: NCT00596375|
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Fevers Pain||Procedure: Lubricant Instillation Drug: Lidocaine Lubricant||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Lidocaine Lubricant Use as an Anesthetic Agent in Emergency Room Urethral Catheterization|
|Study Start Date :||August 2006|
|Actual Study Completion Date :||March 2007|
No Intervention: Routine Care Group
The routine care group will help us to quantify the routine amount of distress associated with catheterization.
Experimental: Lidocaine Group
A experimental group will include patients who will have 2% Lidocaine instilled into the urethra prior to catheterization. This group of subjects receiving routine care plus Lidocaine, will be evaluated during each of the four phases of the intervention.
Drug: Lidocaine Lubricant
2% Lidocaine lubricant instillation prior to urethral catheterization
This group will undergo catheterization utilizing routine care plus lubricant jelly instilled into the urethra. This placebo group will aid in discerning the effects of instillation into the urethra on pain and associated distress.
Procedure: Lubricant Instillation
Lubricant jelly instilled in urethra prior to catheterization
- Modified Behavior Pain Scale [ Time Frame: Procedure (approx. 6 minutes) ]
- Lidocaine Concentration [ Time Frame: Procedure (approx. 6 minutes) ]
- Visual Analog Scale [ Time Frame: Procedure (approx. 6 minutes) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596375
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Michael Greenwald, MD||Children's Healthcare of Atlanta|
|Study Director:||Patrick P Mularoni, MD||Johns Hopkins All Children's Hospital|