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Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Phase 4

Conditions

AICDS Implantation Pediatrics
Analgesia After Pacemaker

Treatments

Drug: B Group
Drug: LA group

Study type

Interventional

Funder types

Other

Identifiers

NCT04184349
HSC-MS-19-0760

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.

Enrollment

19 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab

Exclusion criteria

  • parent or patient refusal
  • use of narcotic medications prior to procedure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

Local Anesthetic (LA Group)
Active Comparator group
Treatment:
Drug: LA group
B group
Active Comparator group
Treatment:
Drug: B Group

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kelbie J Kerr; Olga Pewelek, MD

Data sourced from clinicaltrials.gov

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