Compare the Effects of 0 mg/kg, 0.1 mg/kg, 0.3 mg/kg and 0.5 mg/kg Esketamine on Emergence Agitation After Tonsillectomy and Adenoidectomy in Children: A Randomized Control Trial.

BACKGROUND

The probability of children experiencing emergence agitation (EA) in post-anesthesia care unit (PACU) undergoing adenoidectomy and tonsillectomy is up to 80%. This study investigated the effects of pre-anesthesia sedation of esketamine at 0mg/kg (Control group), 0.1mg/kg, 0.3mg/kg and 0.5mg/kg on EA in children.

METHODS

164 children aged 3-10 years, with American Society of Anesthesiologists (ASA) class I-II were included. Children were randomly divided into groups k0, k1, k3 and k5, and the intravenous anesthesia doses of esketamine were 0 mg/kg, 0.1 mg/kg, 0.3 mg/kg and 0.5 mg/kg, respectively. EA occurrence was assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED) and Watcha scale. Anesthesia time, operation time, tracheal catheter removal time, PACU stay time, hospital stay, postoperative face, legs, activity, crying, consolability scale (FLACC), analgesia needs, heart rate (HR), mean arterial pressure (MAP) at different times, and postoperative complications were also recorded in the four groups.

RESULTS

There were significant statistical differences in PAED scores [13.00 (7.75), 10.00 (6.00), 9.00 (4.00), 9.00 (2.00), p=0.002], Watcha scores [3.00 (1.00), 3.00 (1.00), 2.00 (1.00), 2.00 (1.00), p<0.001], occurrence of postoperative EA [25 (62.5%), 21 (56.8.8%), 10 (25.6%), 7 (18.9%), p<0.001], and severe postoperative EA [20 (50.0%), 11 (29.7%), 4 (10.3%), 3 (8.1%), p<0.001] among the groups k0, k1, k3 and k5. There were no significant differences in operation time, duration of anesthesia, postoperative analgesia and antiemetic needs, and residence time in the PACU among the 4 groups (p>0.05). The 0.5 mg/kg group significantly increased the time required for tracheal catheter removal (p<0.05). The differences in HR and MAP among the four groups were statistically significant (p<0.05).

CONCLUSION

Intravenous administration of esketamine at dose of 0mg/kg, 0.1mg/kg, 0.3mg/kg, and 0.5mg/kg before anesthesia induction leads to differences in the PAED score and incidence of EA of children after adenoidectomy and tonsillectomy. 0.3 mg/kg esketamine appears to offer the optimal balance between efficacy and safety in reducing EA.

TRIAL REGISTRATION NUMBER: ChiCTR2300075038. The trial is publicly available and is registered at www.chictr.org.cn on August 23, 2023.