Nalbuphine in Pediatric Emergence Agitation Following Cochlear Implantation: A Randomized Trial.
Humans
Nalbuphine
/ administration & dosage
Child, Preschool
Male
Double-Blind Method
Female
Prospective Studies
Infant
Emergence Delirium
/ prevention & control
Cochlear Implantation
/ adverse effects
Analgesics, Opioid
/ administration & dosage
Dose-Response Relationship, Drug
Psychomotor Agitation
/ drug therapy
cochlear implantation
emergence agitation
nalbuphine
postoperative pain
Journal
Drug design, development and therapy
ISSN: 1177-8881
Titre abrégé: Drug Des Devel Ther
Pays: New Zealand
ID NLM: 101475745
Informations de publication
Date de publication:
2024
2024
Historique:
received:
21
11
2023
accepted:
30
04
2024
medline:
15
7
2024
pubmed:
15
7
2024
entrez:
15
7
2024
Statut:
epublish
Résumé
To investigate the effects of nalbuphine on emergency agitation (EA), which affects up to 80% of the children following otolaryngology procedures, in children undergoing cochlear implantation. A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded. A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively ( Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring. ChiCTR2000040407.
Sections du résumé
Background
UNASSIGNED
To investigate the effects of nalbuphine on emergency agitation (EA), which affects up to 80% of the children following otolaryngology procedures, in children undergoing cochlear implantation.
Methods
UNASSIGNED
A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded.
Results
UNASSIGNED
A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively (
Conclusion
UNASSIGNED
Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring.
Trial Registration
UNASSIGNED
ChiCTR2000040407.
Identifiants
pubmed: 39006192
doi: 10.2147/DDDT.S451089
pii: 451089
pmc: PMC11244056
doi:
Substances chimiques
Nalbuphine
L2T84IQI2K
Analgesics, Opioid
0
Types de publication
Journal Article
Randomized Controlled Trial
Case Reports
Clinical Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2837-2845Informations de copyright
© 2024 Li et al.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest in this work.