Lidocaine Lubricant in Pediatric Urethral Catheterization

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.

Conditions

• Fevers
• Pain

Interventions

PROCEDURE

Lubricant Instillation

Lubricant jelly instilled in urethra prior to catheterization

DRUG

Lidocaine Lubricant

2% Lidocaine lubricant instillation prior to urethral catheterization

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Children's Healthcare of Atlanta

  lead OTHER

Principal Investigators

• Michael Greenwald, MD · Children's Healthcare of Atlanta

• Patrick P Mularoni, MD · Johns Hopkins All Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-31

Completion

2007-03-31

Countries

• United States

Study Locations