Nalbuphine reduces the incidence of emergence agitation in children undergoing Adenotonsillectomy: A prospective, randomized, double-blind, multicenter study.

Abstract

OBJECTIVE:

To evaluate the effect of nalbuphine on emergence agitation (EA) in children undergoing adenotonsillectomy.

DESIGN:

Multicenter, prospective, double-blind, randomized controlled trial.

SETTING:

The First People's Hospital of Foshan and three other participating institutions in China, from April 2020 to December 2021.

PATIENTS:

Eight hundred patients, 3-9 years of age, American Society of Anesthesiologists (ASA) classification I or II, undergoing elective adenotonsillectomy were included.

INTERVENTIONS:

Nalbuphine (0.1 mg/kg) or saline was administered intravenously.

MEASUREMENTS:

The incidence of EA; the pediatric anesthesia emergence delirium (PAED) scale; and the faces, legs, activity, cry, and consolability (FLACC) scales. Extubation time, duration of post-anesthesia care unit (PACU) stay, anesthesia nurses' and parents' satisfaction, and other side effects.

MAIN RESULTS:

The incidence of EA in the nalbuphine group was lower than that in the saline group 30 min after extubation (10.28% vs. 28.39%, P = 0.000). In addition, the FLACC scores in the nalbuphine group were lower than those in the saline group 30 min after extubation (P < 0.05). Furthermore, the proportion of moderate-to-severe pain cases (FLACC scores >3) was significantly lower in the nalbuphine group than in the saline group (33.58% vs. 60.05%, P = 0.000). Adjusting the imbalance of postoperative pain intensity, the risk of EA was still lower in the nalbuphine group at 0 min (OR, 0.39; 95% CI, 0.26-0.60; P = 0.000), (OR, odds ratio; CI, confidence interval), 10 min (OR, 0.39; 95% CI, 0.19-0.79; P = 0.01), and 20 min (OR, 0.27; 95% CI, 0.08-0.99; P = 0.046) than in the saline group. There were no significant differences in extubation time, duration of PACU stay, nausea and vomiting, or respiratory depression between the two groups (P > 0.05).

CONCLUSION:

Nalbuphine reduced the incidence of EA in children after adenotonsillectomy under general anesthesia, which may be involved in both analgesic and non-analgesic pathways.

• Authors: Jian He, Lei Zhang, Tao Tao, Xianjie Wen, Daguang Chen, Xueqin Zheng, Changhui Luo, Hua Liang, Hanbing Wang
• Journal: Journal of clinical anesthesia (J Clin Anesth) Vol. 85 Pg. 111044 (05 2023) ISSN: 1873-4529 [Electronic] United States
• PMID: 36566649 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
• Copyright: Copyright © 2022. Published by Elsevier Inc.

Chemical References

• Nalbuphine
• Sevoflurane

Topics

• Child
• Humans
• Emergence Delirium (epidemiology, etiology, prevention & control)
• Nalbuphine (adverse effects)
• Sevoflurane
• Incidence
• Prospective Studies
• Anesthesia, General (adverse effects)
• Double-Blind Method
• Anesthesia Recovery Period