Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization
|ClinicalTrials.gov Identifier: NCT01133119|
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : August 16, 2013
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 or disease||Intervention/treatment||Phase|
|Pain||Drug: Standard of Care Drug: Standard of Care plus bupivacaine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization: A Randomized Controlled Trial.|
|Study Start Date :||February 2010|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
|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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133119
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Leland Benson, MD||The Hospital for Sick Children|