Pediatric anesthesia & critical care

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

J Clin AnesthPublished Randomised controlled trial

Authors' 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.

Study context

Population
Children 3–9 years of age, American Society of Anesthesiologists (ASA) I or II, undergoing elective adenotonsillectomy, multicenter in China
Participants
800 children
Comparison
Nalbuphine vs saline
Primary endpoint
Incidence of emergence agitation (EA)
Follow-up
30 min after extubation
Methodological detailsmulticentre, prospective, double-blind
  • Multicentre
  • Prospective
  • Double-blind

Primary result

As reported in the abstract

P = 0.000

Further findings

Moderate-to-severe pain (FLACC scores >3)

P = 0.000

OutcomeOR (95% CI)P value
Risk of EA adjusted for postoperative pain intensity · 0 minAdjusted for imbalance of postoperative pain intensity0.39 (0.26–0.60)P = 0.000
Risk of EA adjusted for postoperative pain intensity · 10 minAdjusted for imbalance of postoperative pain intensity0.39 (0.19–0.79)P = 0.01
Risk of EA adjusted for postoperative pain intensity · 20 minAdjusted for imbalance of postoperative pain intensity0.27 (0.08–0.99)P = 0.046
OutcomeP value
FLACC scores · 30 min after extubationP < 0.05
Extubation time, PACU LOSP > 0.05

Faces, legs, activity, cry, and consolability (FLACC) scores · 30 min after extubation

FLACC scores lower in the nalbuphine group than in the saline group

Extubation time, post-anesthesia care unit (PACU) LOS

No significant differences between the two groups

Safety

OutcomeP value
Nausea and vomiting, respiratory depressionP > 0.05

Nausea and vomiting, respiratory depression

No significant differences between the two groups

Original publication

Nalbuphine reduces the incidence of emergence agitation in children undergoing Adenotonsillectomy: A prospective, randomized, double-blind, multicenter study. J Clin Anesth. Published 23 December 2022. doi:10.1016/j.jclinane.2022.111044

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