Phase 4
Completed N=19
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
Source: ClinicalTrials.gov NCT04184349 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram — 0.035; 0.008 MME per kg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 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 | — |
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
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. Informational only — not medical advice.