Phase 4 N=19 Randomized Treatment

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

Analgesia After Pacemaker · AICDS Implantation Pediatrics

Bottom Line

View on ClinicalTrials.gov: NCT04184349 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram — 0.035; 0.008 MME per kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: LA group (Drug); B Group (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram	0.021; 0.008	—
PRIMARY Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram	0.021; 0.008	—
SECONDARY Pain as Measured by the Visual Analog Scale (VAS) Pain Score	1.33; 3.44	—
SECONDARY Pain as Measured by the Visual Analog Scale (VAS) Pain Score	1.33; 3.44	—
SECONDARY Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale	1.28; 1.62	—
SECONDARY Number of Patients With the Incidence of Pruritis	0; 0	—
SECONDARY Number of Patients With the Incidence of Nausea/Vomiting	0; 0	—
SECONDARY Number of Patients With Respiratory Depression	0; 0	—
SECONDARY Number of Patients With Local Anesthetic Toxicity	0; 0	—
SECONDARY Number of Patients With Incidence of Pneumothorax	0; 0	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04184349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.