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Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lee Benson, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01133119
First received: April 1, 2010
Last updated: August 15, 2013
Last verified: August 2013
History of Changes
  Purpose

In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of congenital heart defects. Procedures are performed under general anesthetic and involve inserting a catheter through the skin and into the femoral vein or artery in the groin. In addition, the use of local anesthetic as a pain control regimen just prior to the removal of femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while the child is under general anesthetic, with the goal of decreasing pain at the insertion site and promoting comfort in the post-operative period. The use of local anesthetic depends on the choice of the individual practitioner and is not currently a routine practice for all patients.

The investigators proposed research seeks to investigate whether the use of subcutaneous bupivacaine reduces pain levels in the post-operative period in children having cardiac catheterization procedures.


Condition Intervention Phase
Pain
 Drug: Standard of Care
Drug: Standard of Care plus bupivacaine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization: A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Self-reported levels of pain [ Time Frame: For 6 hours after admission to the CDIU ] [ Designated as safety issue: No ]

    The primary outcome measure is self-reported levels of pain using the Numerical Rating Scale (NRS). Patients will be asked to verbally rate the amount of femoral pain experienced between 0-10 on admission to CDIU recovery, and at 15 and 30 minutes, and 1, 2, 4, and 6 hours after admission.

    We will be examining the change in pain scores over time as well as the total pain experienced by the paitents. These measures will be compared between the two treatment groups.



Secondary Outcome Measures:
  • Use of analgesics [ Time Frame: 6 hours post-operatively ] [ Designated as safety issue: No ]
    Intervention groups will be able to receive additional analgesia as needed, and the type and amount of medication received will be recorded by nursing staff

  • Use of a suture to close the femoral artery [ Time Frame: Post-operatively ] [ Designated as safety issue: No ]
    If used, this suture is removed post-operatively and may influence post-operative pain levels. We would like to record whether a suture was used and removed as part of our data collection.
Estimated Enrollment: 140
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group 1 Drug: Standard of Care
Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of bupivacaine.
Experimental: Treatment Group 2 Drug: Standard of Care plus bupivacaine

Subcutaneous dose of 0.25% bupivacaine infiltrated around the entry site of the femoral artery/vein sheath, just prior to sheath removal.

Participants will receive a dose of up to 0.8mL/kg (up to 2.0 mg/kg) of 0.25% bupivacaine, with the final amount at the discretion of the physician.

Detailed Description:

A number of differences in pediatric cardiac catheterization procedures exist that limit the transferability of research findings from the adult literature. For example, the majority of pediatric cardiac catheterizations are performed under general anesthetic, and femoral sheaths are removed while under general anesthetic and at the end of the procedure. In contrast in adult clinical practice, procedures are not performed under general anesthetic, and femoral sheaths are removed when patients are awake and often 4 to 6 hours after the end of the procedure. These differences limit the ability to apply research findings in adults to pediatrics, warranting further study of the effects of local anesthetic on femoral site pain in children. As well, studies in adults have examined pain only up to 20 minutes after sheath removal. We seek to investigate the impact of bupivacaine up to 6 hours after cardiac catheterization in children.

  Eligibility
Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 7-18 years
  2. Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic
  3. Ability to speak and understand English
  4. No apparent cognitive impairments

Exclusion Criteria:

  1. Known allergies to bupivacaine
  2. Impaired renal function
  3. Impaired hepatic function
  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: NCT01133119

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Leland Benson, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Lee Benson, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01133119     History of Changes
Other Study ID Numbers: 1000013970
Study First Received: April 1, 2010
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
cardiac catheterization
local anesthetic
pain experienced post-operatively
pediatric patients

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Bupivacaine
Central Nervous System Agents
Central Nervous System Depressants
 Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015