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Effective doses of esketamine oral or esketamine intranasal for the prevention of preoperative anxiety in pediatric patients: A randomized double-blind dose-finding trial

Hongfei Xiong, Yingxue Xu, Jiayi Liu, Guangbo Liu, Yunyun Zhang, Ziwen Wei, Wenwen Liang, Xuemei Zhao, Siyuan Li, Gang Xiao, Rongliang Xue

Medicine March 6, 2026 DOI: 10.1097/md.0000000000048048 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Double-blind Peer reviewed
Population Pediatric population
Intervention Esketamine
Dose oral ED95: 8.2125 mg/kg; intranasal ED95: 2.1770 mg/kg
Topics Anxiety Ketamine Esketamine
Keywords Nasal administration Anesthesia Randomized controlled trial Adverse effect Clinical trial
Key findings Single-dose esketamine, administered orally or intranasally, effectively mitigates preoperative anxiety in children, with specific ED95 values for each route.

Abstract

This study demonstrates the efficacy of single-dose esketamine regimens, administered orally (ED95: 8.2125 mg/kg; 95% CI: 7.4250-8.4597 mg/kg) and intranasally (ED95: 2.1770 mg/kg; 95% CI: 2.0952-2.1958 mg/kg), in mitigating preoperative anxiety within a pediatric population. These findings highlight the safety and efficacy of esketamine for this patient group.

Comparable studies

Other randomized controlled trials on esketamine for anxiety, most cited first.

Study Year Design Participants
Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant Patients with treatment resistant depression 2020 Randomized controlled trial
Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response Patients with treatment-resistant depression 2021 Pooled post hoc analysis of two phase 3, double-blind, active-controlled studies
Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray Patients with treatment-resistant depression 2023 Post hoc analysis of two pooled phase 3 double-blind placebo- and active-controlled trials n = 518
Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant Patients aged 18-64 years with treatment-resistant depression 2023 Phase 3, randomized, double-blind, short-term flexibly dosed study n = 223
The effect of esketamine on postoperative anxiety and depression in patients with thyroid cancer: A randomized, double-blind, placebo-controlled, parallel-group trial. Female patients with thyroid cancer scheduled for surgery under general anesthesia 2025 Randomized controlled trial n = 80

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