"Transcutaneous auricular vagus nerve stimulation" improves recovery quality after tonsil and/or adenoidectomy in children (PedSQoR): a multicenter, randomized, double-blind controlled trial

INTERVENTION: ta‐VNS group :The active stimulation group received active electrical stimulation of the left concha cymba (stimulation frequency 10 Hz, pulse width 200µs, 30 seconds on/30 seconds off). The first stimulation began after the child arrived at the preoperative preparation area, assisted by a guardian or parent to wear the device. Stimulation was continued throughout the surgery. After the operation, the child was transferred to the PACU for continued stimulation, which was stopped and the stimulator removed once the endotracheal tube was removed. To determine the stimulation intensity: starting from 0.4V, it was adjusted in increments of 0.4V until the child reached a sensation of pricking pain, then set to a level that the child could tolerate without pain.Throughout the entire stimulation period, guardians and researchers were present to observe, in case of dropout or if the child showed discomfort, allowing for timely intervention. ;Sham stimulation group:The sham stimulation group received treatment with the same cycle. Sham stimulation was delivered via electrodes placed on the left concha of the ear, with stimulus intensity adjusted using the same method as the active stimulation group. All procedures of the active stimulation group were simulated, and after one minute, the power was turned off to mimic the sham state.; CONDITION: Tonsillar or Adenoidal Hypertrophy PRIMARY OUTCOME: Pediatric Scale for Quality of Recovery; SECONDARY OUTCOME: Postoperative pain scores and pain incidence rate;The incidence of delirium during the emergence period;Recovery time;Nausea and vomiting;Adverse event; INCLUSION CRITERIA: 1. Children aged 5–12 years; 2. Patients diagnosed with tonsillar and/or adenoidal hypertrophy at the Affiliated Heping Hospital of Changzhi Medical College in Shanxi Province or the Women and Children's Health Care Hospital of Changzhi City, Shanxi Province, who are scheduled to undergo tonsillectomy and/or adenoidectomy under general anesthesia; 3. American Society of Anesthesiologists (ASA) physical status classification I–II; 4. The child/patient and guardian can understand the content of the Chinese version of the scale and cooperate with the relevant assessment.