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: April 18, 2018
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Lee Benson, The Hospital for Sick Children

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Standard of Care; Drug: Standard of Care plus bupivacaine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

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

More Information

Additional Information:

Link to published study results 

• Responsible Party: Lee Benson, Staff Cardiologist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT01133119
• Other Study ID Numbers: 1000013970
• First Posted: May 28, 2010
• Last Update Posted: April 18, 2018
• Last Verified: August 2013

Keywords provided by Lee Benson, The Hospital for Sick Children:

cardiac catheterization; local anesthetic; pain experienced post-operatively; pediatric patients

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents