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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133119
First Posted: May 28, 2010
Last Update Posted: August 16, 2013
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.
Information provided by (Responsible Party):
Lee Benson, The Hospital for Sick Children
April 1, 2010
May 28, 2010
August 16, 2013
February 2010
February 2013   (Final data collection date for primary outcome measure)
Self-reported levels of pain [ Time Frame: For 6 hours after admission to the CDIU ]

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.

Same as current
Complete list of historical versions of study NCT01133119 on ClinicalTrials.gov Archive Site
  • Use of analgesics [ Time Frame: 6 hours post-operatively ]
    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 ]
    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.
Use of analgesics [ Time Frame: 6 hours post-operatively ]
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
Not Provided
Not Provided
 
Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization
Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization: A Randomized Controlled Trial.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Pain
  • Drug: Standard of Care
    Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of bupivacaine.
  • 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.

  • Active Comparator: Treatment Group 1
    Intervention: Drug: Standard of Care
  • Experimental: Treatment Group 2
    Intervention: Drug: Standard of Care plus bupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
7 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01133119
1000013970
No
Not Provided
Not Provided
Lee Benson, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Leland Benson, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP