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Abstract
Background
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
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
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 (P < 0.001), without affecting the extubation time and PACU length of stay. More children (34.6%) in the 0.9% saline group experienced severe EA. Higher dose nalbuphine (0.15 mg/kg, 0.2 mg/kg) showed lower peak PAED score, better analgesia and sedation effect compared with 0.1 mg/kg nalbuphine and saline groups. However, 0.2mg/kg nalbuphine caused undesired over-sedation in two (7.7%) children. No other adverse events were reported.
Conclusion
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
ChiCTR2000040407.
Abbreviations
ASA, American Society Anesthesiologists; EA, emergency agitation; FLACC, the Faces, Legs, Activity, Cry, and Consolability; GEE, Generalized linear mixed; MRI, magnetic resonance imaging; PAED, Pediatric Anesthesia Emergence Delirium; PACU, post-anesthesia care unit; PONV, postoperative nausea and vomiting; SD, standard deviation.
Data Sharing Statement
The raw data are available upon reasonable requests to the corresponding authors.
Ethics Approval and Informed Consent
The study protocol was reviewed and approved by the ethics committee of Xijing Hospital (KY20202089-F-1) and was registered at the Chinese Clinical Trial Registry (ChiCTR2000040407) on November 28, 2020. The parents or healthcare guardians signed the informed consent.
Acknowledgments
The authors appreciate the staff in the operating room and PACU for their assistance during data collection.
Disclosure
The authors report no conflicts of interest in this work.