Postoperative pain after adenoid and tonsil surgery is significant, with approximately 75% of pediatric patients experiencing severe postoperative pain. Currently, there is a lack of clinical strategies to safely and effectively manage postoperative pain in children undergoing adenoid and tonsil surgery. Dexmedetomidine and esketamine can achieve appropriate sedation levels and alleviate postoperative pain when used in children. Both drugs can be administered intranasally, and their pharmacological effects complement each other, reducing side effects. This study aims to investigate whether intranasal administration of dexmedetomidine-esketamine combination can improve postoperative analgesia in children undergoing adenoid and tonsil surgery.
Aged 3-7 years old.
Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.
Provides written informed consent by the guardian.
Unsuitable for intranasal administration due to nasal diseases (such as rhinitis, nasal polyps, or any condition causing nasal congestion).
Clearly diagnosed cardiovascular and respiratory diseases.
Communication barriers due to delayed neurological development or visual or hearing impairments.
Traumatic brain injury or neurosurgery.
Parallel
Intranasal dexmedetomidine-esketamine
DrugA mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.
Intranasal placebo (normal saline)
DrugPlacebo (normal saline) will administered intranasally after anesthesia induction.
Area under curve of pain intensity within 48 hours after surgery
Pain intensity will be assessed with the Face, Legs, Activity, Cry, Consolability scale (FLACC; scores range from 0 to 10, with higher scores indicating more severe pain intensity) at 10, 20, an 30 minutes after entering the post-anesthesia care unit (PACU), at 3 and 6 hours after surgery, and then twice daily (8:00-10:00 am, 6:00-8:00 pm) until 48 hours after surgery.
Sleep quality during the first three nights after surgery
Sleep quality will be assessed by the guardians using the numeric rating scale (NRS; a 0-10 scale where 0=the best sleep and 10=the worst sleep) in the first three morning (8:00-10:00 am) after surgery.
Cumulative consumption of analgesics within 48 hours
Cumulative consumption of analgesics within 48 hours after surgery.
Time to extubation after surgery
Time to extubation at the end of surgery.
Length of stay in PACU
Length of stay in PACU after surgery.
Incidence of adverse events during PACU stay
Adverse events are defined as any events that required intervention during PACU stay, including laryngospasm, bronchospasm, airway obstruction, nausea and vomiting, desaturation (pulse oxygen saturation \<90%), bradycardia (heart rate \<60 beats per minute), bleeding, and others.
Length of stay in hospital after surgery
Length of stay in hospital after surgery.
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