Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Standard of Care; Standard of Care plus bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of 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.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: cardiac catheterization; local anesthetic; pain experienced post-operatively; pediatric patients