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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Standard of Care; Drug: Standard of Care plus bupivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Active Comparator: Treatment Group 1	Drug: Standard of Care; Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 6 hours after admission to the CDIU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Post-operatively

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Leland Benson, MD, The Hospital for Sick Children

Publications and helpful links

Helpful Links

• Link to published study results

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: cardiac catheterization; pediatric patients; local anesthetic; pain experienced post-operatively
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1000013970