A Phase 2 interventional study of Standard of Care and Standard of Care plus bupivacaine in Pain, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to male participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Standard of Care
Drug: Standard of Care plus bupivacaine
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.
Self-reported levels of pain
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.
Time frame: For 6 hours after admission to the CDIU
Use of analgesics
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
Time frame: 6 hours post-operatively
Use of a suture to close the femoral artery
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.
Time frame: Post-operatively
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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