drugset / Trial / NCT01133119

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

NCT01133119

Phase 2 Completed 140 enrolled The Hospital for Sick Children
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-02
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Subcutaneous
Subject Bupivacaine Other / unclassified 2 mg/kg Subcutaneous

Indications

No indication recorded.