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| Sponsor: | Children's Healthcare of Atlanta |
|---|---|
| Collaborator: |
Emory University |
| Information provided by: | Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT00596375 |
Purpose
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 | Intervention |
|---|---|
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Fevers Pain |
Procedure: Lubricant Instillation Drug: Lidocaine Lubricant |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Lidocaine Lubricant Use as an Anesthetic Agent in Emergency Room Urethral Catheterization |
| Enrollment: | 47 |
| Study Start Date: | August 2006 |
| Study Completion Date: | March 2007 |
| Arms | Assigned Interventions |
|---|---|
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No Intervention: Routine Care Group
The routine care group will help us to quantify the routine amount of distress associated with catheterization.
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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.
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Drug: Lidocaine Lubricant
2% Lidocaine lubricant instillation prior to urethral catheterization
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Experimental: Instillation
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.
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Procedure: Lubricant Instillation
Lubricant jelly instilled in urethra prior to catheterization
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Months to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | All Children's Hospital |
More Information
| Responsible Party: | Michael Greenwald, MD, Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT00596375 History of Changes |
| Other Study ID Numbers: | 06693 |
| Study First Received: | January 8, 2008 |
| Last Updated: | January 16, 2008 |
| Health Authority: | United States: Institutional Review Board |
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Lidocaine Infant Urinary Catheterization Emergency Medicine Analgesia |
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Anesthetics Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |