Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and irritation in the upper airway. The primary aim of this clinical trial is to evaluate whether preoperative administration of nebulized lidocaine reduces the incidence and severity of emergence agitation compared to normal saline in pediatric patients undergoing elective tonsillectomy under sevoflurane anesthesia.
Participants are randomly allocated into two study groups in a 1:1 ratio:
* Group A (Lidocaine Group): Receives preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to 4 mL) administered via a nebulizer. * Group B (Control Group): Receives preoperative inhalation of an identical volume (4 mL) of 0.9% normal saline placebo via a nebulizer.
Both groups receive a standardized sevoflurane-based general anesthetic. Emergence agitation is evaluated during the first 30 minutes following anesthesia cessation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes evaluate postoperative pain severity (FLACC scale), rescue analgesic and sedative requirements, time to extubation, PACU length of stay, and airway-related or systemic complications.
Pediatric patients scheduled for elective tonsillectomy operation
Patients below 9 years of age
American Society of Anesthesiologists (ASA) physical status I or II
Written informed consent provided by a parent or legal guardian
Emergency surgical cases, including patients presenting with active tonsillar bleeding
American Society of Anesthesiologists (ASA) physical status III or IV
Known hypersensitivity or allergy to lidocaine, amide local anesthetics, or sevoflurane
Pre-existing upper airway obstruction, active lower respiratory tract infection, or severe reactive airway disease
Parallel
Lidocaine
DrugPreoperative administration of 2% preservative-free lidocaine at a dose of 2 to 4 mg/kg, diluted to a total volume of 4 mL, delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
0.9% Normal Saline
DrugPreoperative administration of an identical volume of 4 mL of 0.9% normal saline delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
Pediatric Anesthesia Emergence Delirium (PAED) Scale Score
Evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale assesses 5 behavioral items: eye contact (0-4), purposeful actions (0-4), awareness of surroundings (0-4), restlessness (0-4), and consolability (0-4). Total scores range from 0 to 20, where higher scores indicate greater severity of emergence agitation/delirium.
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