Lidocaine Lubricant in Pediatric Urethral Catheterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596375
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
Emory University
Information provided by:
Children's Healthcare of Atlanta

Brief 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 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
Allocation: Randomized
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

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U.S. FDA Resources

Arm Intervention/treatment
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
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.
Procedure: Lubricant Instillation
Lubricant jelly instilled in urethra prior to catheterization

Primary Outcome Measures :
  1. Modified Behavior Pain Scale [ Time Frame: Procedure (approx. 6 minutes) ]

Secondary Outcome Measures :
  1. Lidocaine Concentration [ Time Frame: Procedure (approx. 6 minutes) ]
  2. Visual Analog Scale [ Time Frame: Procedure (approx. 6 minutes) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00596375

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Emory University
Principal Investigator: Michael Greenwald, MD Children's Healthcare of Atlanta
Study Director: Patrick P Mularoni, MD Johns Hopkins All Children's Hospital

Responsible Party: Michael Greenwald, MD, Children's Healthcare of Atlanta Identifier: NCT00596375     History of Changes
Other Study ID Numbers: 06693
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: December 2007

Keywords provided by Children's Healthcare of Atlanta:
Urinary Catheterization
Emergency Medicine

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action