Lidocaine Lubricant in Pediatric Urethral Catheterization

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00596375
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: December 2007
  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
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

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • Modified Behavior Pain Scale [ Time Frame: Procedure (approx. 6 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lidocaine Concentration [ Time Frame: Procedure (approx. 6 minutes) ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale [ Time Frame: Procedure (approx. 6 minutes) ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: August 2006
Study Completion Date: March 2007
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596375

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on September 18, 2014