A Phase 3 interventional study of Lidocaine and 0.9% Normal Saline in Emergence Agitation, Emergence Delirium and Postoperative Pain, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Assiut University · Phase 3, Interventional, and Prevention
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:
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.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 491 interventional studies indexed under Emergence Delirium.
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Patients in this arm receive preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to a total volume of 4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
Drug: Lidocaine
Patients in this arm receive preoperative inhalation of an identical volume of 0.9% normal saline (4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
Drug: 0.9% Normal Saline
Preoperative 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.
Also known as: Lignocaine, 2% Preservative-Free Lidocaine, Nebulized Lidocaine
Preoperative 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.
Time frame: 30 minutes after anesthesia discontinuation
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine