Pediatric anesthesia & critical care
Nalbuphine reduces the incidence of emergence agitation in children undergoing Adenotonsillectomy: A prospective, randomized, double-blind, multicenter study
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
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| Risk of EA adjusted for postoperative pain intensity · 0 minAdjusted for imbalance of postoperative pain intensity | 0.39 (0.26–0.60) | P = 0.000 | |
| Risk of EA adjusted for postoperative pain intensity · 10 minAdjusted for imbalance of postoperative pain intensity | 0.39 (0.19–0.79) | P = 0.01 | |
| Risk of EA adjusted for postoperative pain intensity · 20 minAdjusted for imbalance of postoperative pain intensity | 0.27 (0.08–0.99) | P = 0.046 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | P value |
|---|---|
| FLACC scores · 30 min after extubation | P < 0.05 |
| Extubation time, PACU LOS | P > 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
| Outcome | P value |
|---|---|
| Nausea and vomiting, respiratory depression | P > 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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