Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Active taVNS Group: Active taVNS Group：The taVNS device delivers electrical stimulation via an ear-clip electrode placed on the left cymba conchae.Parameters: 25 Hz frequency, 300 µs pulse width, 30 s ON / 30 s OFF duty cycle.Applied from pre-induction through postoperative recovery, then twice daily for 30 min on POD 1-2.Intensity adjusted to induce mild tingling without discomfort.

Sham stimulation group: The sham stimulation device is visually identical to the active taVNS unit. Electrodes are placed on the same auricular site, and procedures mimic active stimulation, but no electrical current is delivered.Used to maintain blinding and control for placebo effects.

Study summary

Brief Summary This study is designed to find out whether transcutaneous auricular vagus nerve stimulation (taVNS) can safely reduce restlessness and confusion when children wake up from anesthesia after tonsillectomy and adenoidectomy. These problems, called emergence agitation and delirium, are common after surgery and can cause distress for both children and their families.TaVNS is a non-invasive treatment that delivers mild electrical stimulation to a specific area of the ear connected to the vagus nerve. It does not involve needles or medication, and children usually feel only a gentle tingling sensation.In this randomized, double-blind study, children will be assigned by chance to receive either taVNS or a sham (placebo) stimulation during surgery. Neither the children, their families, nor the medical team providing care will know which treatment each child receives.Researchers will observe and record how calmly children wake up from anesthesia, whether they show signs of delirium, and any side effects. The goal of this study is to test whether taVNS is an effective and safe way to improve recovery and comfort for children after surgery.

Eligibility

Primary outcome measure(s)

• The incidence of emergence delirium (ED) — Every 10 min during after the patient removed the endotracheal tube ，in the first 30 min in the Post-Anesthesia Care Unit (PACU).
  Measurement Tools: Diagnosis will be made using the Pediatric Anesthesia Emergence Delirium (PAED) Scale (score range: 0-20, higher scores indicate worse delirium) and the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Scale (score range: 0-10, higher scores indicate worse pain). Diagnostic Criteria: 1. ED is defined as a PAED score ≥ 10 and a FLACC score \< 4. 2. If both PAED score ≥ 10 and FLACC score ≥ 4, the child will first receive intravenous fentanyl 0.5 μg·kg-¹ for analgesia. 3. Five minutes after analgesia, both scales will be reassessed. If the PAED score remains ≥ 10, the diagnosis of ED will be confirmed regardless of the FLACC score.

Trial sites (1)

More The First Affiliated Hospital of Zhejiang Chinese Medical University trials in China

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