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The Impact of Intranasal Esketamine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Controlled Study.

Jiajia Li, Gaili Jia, Ruixian Wang, Ruofang Zheng, Kaiming Yuan

Drug Design, Development and Therapy 2025 DOI: 10.2147/dddt.s553693 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 204
Population Children aged 3-6 years undergoing adenotonsillectomy
Intervention Intranasal esketamine
Dose 0.5 mg/kg, 1 mg/kg
Topics Esketamine
Keywords Adenotonsillectomy Children Emergence agitation Intranasal esketamine Pediatric recovery
Key findings Intranasal esketamine at 0.5 mg/kg significantly reduces emergence agitation incidence compared to placebo, while 1 mg/kg provides no additional benefit and prolongs extubation time.

Abstract

To investigate the efficacy of intranasal esketamine in reducing the incidence of emergence agitation (EA) in pediatric patients undergoing adenotonsillectomy and to determine the optimal dose of esketamine. A total of 204 children aged 3-6 years scheduled for adenotonsillectomy were randomly assigned to three groups. All participants received a standardized anesthetic induction protocol. Following tracheal intubation, they were administered intranasally 0.5 mg/kg esketamine (group LE), 1 mg/kg esketamine (group HE), or an equivalent volume of saline (group C). Anesthesia was maintained with sevoflurane during surgery, and the children were transferred to the post-anesthesia care unit (PACU) after extubation. The highest scores on the Pediatric Anesthesia Emergence Delirium (PAED) scale and the modified Children's Hospital of Eastern Ontario Pain Scale (m-CHEOPS) in the PACU were recorded. The incidence of EA, defined as PAED ≥ 10, was calculated for each group. Additionally, changes in vital signs after intranasal administration, surgery time, anesthesia time, extubation time, eye-opening time, recovery time, and the incidence of adverse reactions were compared among the three groups. Group LE demonstrated a significantly lower incidence of EA compared with group C (10.45% vs 29.85%, P = 0.005), while no significant difference was observed between group LE and HE (10.45% vs 12.12%, P = 0.760). Relative to Group C, children in Group LE also showed significantly lower PAED (P = 0.010) and m-CHEOPS scores (P = 0.023), along with reduced requirements for rescue propofol (P = 0.005) and rescue fentanyl (P = 0.013). Groups LE and HE demonstrated comparable performance across these secondary outcomes; however, extubation time was prolonged in Group HE (P = 0.025). Intranasal esketamine at a dose of 0.5 mg/kg significantly reduces the incidence of EA following pediatric adenotonsillectomy. Increasing the dose to 1 mg/kg does not confer additional benefit in preventing EA and may instead delay extubation.

Comparable studies

Other randomized controlled trials on esketamine, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

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