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

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          Abstract

          Objective: There is no universal agreement on optimal pharmacological regimens for pain management during surgeries. The aim of this study 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 numbers of patients who developed moderate or severe pain (FLACC ≥4 points); time to first rescue analgesic top up and the actual number of rescue pain medicine given in pain control in post-anesthesia care unit (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 5.8 (5.5, 6.1) in the nalbuphine group and 5.6 (5.3, 5.8) in the fentanyl group ( p = 0.2132). FLACC score of nalbuphine group was lower than that of fentanyl group upon patients' arrival at PACU ( p < 0.05). The time to first required rescue dose of pain drug for nalbuphine group was longer than for the fentanyl group (2.5 vs 1.2 h, p < 0.0001). Only one patient (0.6%) in nalbuphine group presented a slow respiratory rate (RR) at 9/min while 29 patients (18.5%) in fentanyl group developed slow RR ≤10/min in PACU. Meanwhile, SpO 2 was lower in the fentanyl group at 10 min after patients’ arrival in PACU ( p < 0.05). 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 Adenotonsillectomy.

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          Nalbuphine

          William Schmidt, S.William Tam, Gregory Shotzberger … (1985)
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            Ceiling effect for respiratory depression by nalbuphine.

            J. A. Romagnoli, A S Keats (1980)
            The respiratory depressant capacities of intravenous nalbuphine, a potent analgesic of the narcotic antagonist type, and of morphine were compared in 23 healthy subjects using displacement of CO2 response by a steady-state method as the index of respiratory depression. At equianalgesic doses of 10 mg/70 kg, respiratory depression by nalbuphine was equal to that by morphine. When increments of 10 mg/70 kg were given hourly the dose-effect curve for respiratory depression by nalbuphine was flatter than that of morphine, and maximum respiratory depression occurred after 30 mg/70 kg. In a separate study of 10 subjects nalbuphine was administered in 10 mg/70 kg increments to a total dose of 60 mg/70 kg; doses in excess of 30 mg/70 kg failed to increase respiratory depression beyond that induced by morphine 20 mg/70 kg. A ceiling effect for respiratory depression previously known to exist only for nalorphine was thereby demonstrated to apply to nalbuphine. The respiratory depression of nalbuphine was readily antagonized by naloxone 0.4 mg, nalorphine 10 mg, and levallorphan 1.0 mg. Subjective effects of nalbuphine were milder than those of morphine, and dysphoria suggestive of the psychotomimetic effects of narcotic antagonists was reported only 4 times in 24 subject exposures. The ceiling effect for respiratory depression by nalbuphine provides a unique safety factor among potent analgesics.
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              A Comparision of Nalbuphine with Morphine for Analgesic Effects and Safety : Meta-Analysis of Randomized Controlled Trials

              Zheng-Yang Zeng, Jianhua Lu, Chang Shu … (2015)
              Although morphine is the standard opioid analgesic for pain control and has been widely used, certain drug-induced adverse effects have been reported as intolerable and need to be addressed. Nalbuphine may have a few advantages over morphine in this respect. We aimed to describe the effect of nalbuphine as well as its saftey compared to morphine by analyzing published randomized controlled trials (RCTs) with meta-analysis approach. We analysed 15 trials (820 patients). Overall, there was no evidence to show that the effect of pain relief had any difference between nalbuphine and morphine (pooled relative risks [RRs], 1.01; 95% CI, 0.91 to 1.11; P = 0.90). On the other hand, the incidences of pruritus, nausea, vomiting, respiratory depression were significantly lower in nalbuphine group compared with morphine group, and the pooled RRs were 0.78(95%CI, 0.602–0.997; P = 0.048) for nausea, 0.65(95%CI, 0.50–0.85; P = 0.001) for vomiting, 0.17(95%CI, 0.09–0.34; P  < 0.0001) for pruritus, and 0.27(95%CI, 0.12–0.57; P = 0.0007) for respiratory depression. The analgesic efficacy of nalbuphine is comparable to morphine, but nalbuphine provides a better safety profile than morphine in the aspect of certain side-effects, especially related to pruritus and respiratory depression.
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                Author and article information

                Contributors
                Journal
                Journal ID (nlm-ta): Front Pharmacol
                Journal ID (iso-abbrev): Front Pharmacol
                Journal ID (publisher-id): Front. Pharmacol.
                Title: Frontiers in Pharmacology
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 1663-9812
                Publication date (Electronic): 09 December 2020
                Publication date Collection: 2020
                Volume: 11
                Electronic Location Identifier: 597550
                Affiliations
                [ 1 ]Key Laboratory of Anesthesiology of Zhejiang Province, Department of Anesthesiology, Perioperative and Pain Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Zhejiang, China
                [ 2 ]Department of Anesthesiology, Beijing Children’s Hospital, Capital Medical University, Beijing, China
                [ 3 ]Department of Anesthesiology, Shanghai Children’s Medical Center, Shanghai, China
                [ 4 ]Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou, China
                [ 5 ]Department of Anesthesiology, Cincinnati Children’s Hospital, Cincinnati, OH, United States
                Author notes
                [†]

                These authors have contributed equally to this work.

                Edited by: Venkata Kashyap Yellepeddi, The University of Utah, United States

                Reviewed by: Mellar Pilgrim Davis, Geisinger Health System, United States

                Meenu Batra, Cincinnati Children’s Hospital Medical Center, United States

                *Correspondence: Junzheng Wu, Junzheng.Wu@ 123456cchmc.org ; Hua-Cheng Liu, huachengliu@ 123456163.com

                This article was submitted to Obstetric and Pediatric Pharmacology, a section of the journal Frontiers in Pharmacology

                Article
                Publisher ID: 597550
                DOI: 10.3389/fphar.2020.597550
                PMC ID: 7849154
                PubMed ID: 33536911
                SO-VID: 7a948e66-c3c7-4d29-98ac-c54342e208f2
                Copyright © Copyright © 2020 Chen, Wang, Zhang, Wang, Zhang, Gu, Song, Chen, Li, Cai, Li, Lian, Wu and Liu.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 21 August 2020
                Date accepted : 16 October 2020
                Page count
                Pages: 0
                Categories
                Subject: Pharmacology
                Subject: Clinical Trial

                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: nalbuphine,fentanyl,analgesic,adenotonsillectomy,children
                Data availability:
                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: nalbuphine, fentanyl, analgesic, adenotonsillectomy, children

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