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

NCT01133119 | Completed Phase 2

• 1 other identifier: 1000013970
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Use of analgesics

  6 hours post-operatively

• Use of a suture to close the femoral artery

  Post-operatively

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

Drug: Standard of Care

Treatment Group 2

EXPERIMENTAL

Drug: Standard of Care plus bupivacaine

Interventions

Standard of Care DRUG

Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of bupivacaine.

Treatment Group 1

Standard of Care plus bupivacaine DRUG

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.

Treatment Group 2

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 7-18 years
• Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic
• Ability to speak and understand English
• No apparent cognitive impairments

You may not qualify if:

• Known allergies to bupivacaine
• Impaired renal function
• Impaired hepatic function

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Links

• Link to published study results

MeSH Terms

Conditions

Pain

Interventions

Standard of Care; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Leland Benson, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: May 28, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 18, 2018

Record last verified: 2013-08

Locations

CA (1)