AUTHOR=Chen Fang , Wang Cheng-Yu , Zhang Jianmin , Wang Fang , Zhang Mazhong , Gu Hongbin , Song Xingrong , Chen Jia , Li Yang , Cai Yu-Hang , Li Jun , Lian Qing-Quan , Wu Junzheng , Liu Hua-Cheng 

TITLE=Comparison of Postoperative Analgesic Effects Between Nalbuphine and Fentanyl in Children Undergoing Adenotonsillectomy: A Prospective, Randomized, Double-Blind, Multicenter Study

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 11 - 2020

YEAR=2020

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.597550

DOI=10.3389/fphar.2020.597550

ISSN=1663-9812

ABSTRACT=Objective: To compare the postoperative analgesic effects of nalbuphine with fentanyl in children undergoing adenotonsillectomy. 
Design, Setting, Participants: We conducted a prospective, randomized, double-blind, non-inferiority and multicenter trial in 311 patients admitted to four different medical facilities in China from October 2017 to November 2018. 
Main Outcome Measure: The primary outcome was postoperative pain score. The secondary outcomes were as follows: the cases of patients who developed moderate or severe pain (FLACC≥4 points); time to 1st rescue analgesic top up and the actual number of rescue pain medicine given in PACU, and additional analgesics requirement (received ≥2 rescue analgesics or/and other analgesics except study medications administered in PACU and ward); emergence and extubation time; Waking up time; time of PACU stay, and other side effects (desaturation, nausea/vomiting etc.).
Results: A total of 356 children were screened and 322 patients were randomized. The mean age was 5.3(4.4, 7.0) in the nalbuphine group and 5.2(4.0, 6.5) in the fentanyl group. FLACC score of nalbuphine group was lower than that of fentanyl group upon patients’ arrival at PACU. The time to 1st required rescue dose of pain drug for nalbuphine group was longer than for the fentanyl group. Only one patient (0.6%) in nalbuphine group presented a slow RR at 9/min while 29 patients (18.5%) in fentanyl group developed slow RR ≤10/min in PACU. Meanwhile, SP02 was lower in the fentanyl group at 10min after patients’ arrival in PACU. The other profiles observed from these two drug groups were similar.
Conclusion: Nalbuphine provided better pain relief with minimal respiration depression than fentanyl in children undergoing Adenoidectomy.