Effect of oral esketamine on preoperative sedation and venipuncture analgesia in pediatric patients: a prospective randomized double-blind controlled clinical trial

Abstract

Abstract Background Anxiety and uncooperation are common among pediatric patients during the preoperative preparation, which requires adequate and appropriate analgesia and sedation. Methods We performed a prospective, randomized, double-blind, controlled clinical trial involving 1–6-year-old pediatric patients scheduled for elective tonsillectomy or adenoidectomy between December 2020 and May 2021. Patients were randomly assigned to control (group C), esketamine 1 mg.kg− 1 (group EK1), or esketamine 2 mg.kg− 1 (group EK2) group. Venipuncture analgesia, cooperation, and sedation, as well as satisfaction upon parent–child separation, cooperation, sedation, and adverse events, were compared among the three groups. Dynamic changes in the sedation score and vital signs were monitored. Results A total of 88 pediatric patients were analyzed, with 29, 29, and 30 patients in groups C, EK1, and EK2, respectively. Compared with group C, groups EK1 and EK2 both had better analgesia during venipuncture (P < 0.001). In addition, better cooperation and sedation was noticed in groups EK1 and EK2 during parent–child separation and venipuncture than in group C. Compared with the baseline, the mean respiratory rate had a significant decrease from 25.6 ± 0.3 to 24.6 ± 0.4 breaths/min at 30 min after the esketamine administration in group EK2, although it was still within normal limits (P = 0.030). There were no significant differences in adverse events among three groups. Conclusions Preoperative oral administration of 1 or 2 mg.kg− 1 esketamine in pediatric patients could achieve effective analgesia and sedation. Oral medication of 2 mg.kg− 1 esketamine had more pronounced effects. Trial registration : This clinical trial was registered at the Chinese Clinical Trial Registry (ChiCTR2000040739) on 08/12/2020.