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The effect of a subclinical dose of esketamine on depression and pain after cesarean section: A prospective, randomized, double-blinded controlled trial.

Xiangqian Wan, Ming Li, Xiantao Li, Huan Dai, Mingqing Peng

Medicine November 1, 2024 DOI: 10.1097/MD.0000000000040295 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Placebo-controlled Double-blind Peer reviewed
Sample size 150
Population Pregnant women undergoing elective cesarean sections
Intervention Esketamine
Dose 0.25 mg/kg
Duration 14 days postpartum
Topics Depression Esketamine
Keywords Pain management Obstetrics Anesthesia Cesarean section Ketamine therapy
Citations 8
Key findings Subclinical doses of esketamine did not reduce the incidence of postpartum depression but significantly lowered postoperative pain scores at 24 hours post-surgery.

Abstract

The aim of this randomized, double-blind placebo-controlled clinical trial was to study the effects of subclinical doses of esketamine on postpartum depression and pain following elective cesarean sections. This randomized, double-blind placebo-controlled trial included 150 pregnant women undergoing elective cesarean sections. After umbilical cord clamping, participants received either subclinical doses of esketamine (0.25 mg/kg, diluted in 10 mL of 0.9% saline) or a placebo (10 mL of 0.9% saline). The primary outcome measures were the incidence of postpartum depression (PPD) and postoperative pain. The Edinburgh Postnatal Depression Scale was used to evaluate PPD on days 3, 7, and 14 postpartum, with an Edinburgh Postnatal Depression Scale score ≥ 10 indicating PPD. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 4, 24, and 48 hours post-surgery. Secondary outcomes included adverse reactions and Ramsay sedation scores at 5 and 15 minutes post-administration. There were no significant differences in the incidence of PPD between the 2 groups on days 3, 7, and 14 postpartum (P > .05). The VAS scores showed significant differences between the 2 groups at 4 and 24 hours postoperatively (P .05). The experimental group had significantly higher adverse reactions and Ramsay sedation scores 5 minutes post-administration compared to the control group (P .05). Subclinical doses of esketamine did not reduce the incidence of PPD at 14 days postpartum but did significantly lower VAS scores at 24 hours post-surgery. The experimental group experienced temporary increases in adverse reactions and Ramsay sedation scores shortly after administration.

Comparable studies

Other randomized controlled trials on esketamine for depression, 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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