Nalbuphine 10mg/1ml solution for injection ampoules

BackgroundUraemic pruritus (UP) is an increasingly significant health burden. However, current treatments are often unsatisfactory and associated with numerous adverse reactions. Recently, several large randomized controlled trials (RCTs) have confirmed that kappa opioid receptor (KOR) agonists, which target the endogenous opioid system, are effective in controlling symptoms. We compared the efficacy and safety of currently available KOR agonists for the treatment of UP.MethodsWe conducted a systematic review and network meta-analysis (NMA) of RCTs to assess the efficacy and safety of KOR agonists in patients with UP. The primary outcomes were pruritus-related scales and adverse events. Two independent reviewers evaluated RCTs for eligibility and extracted relevant data, with discrepancies resolved by consensus or a third reviewer. We utilized a fixed effects model within a Bayesian framework for the NMA. Dichotomous variables were presented as risk ratios (RRs) and continuous variables were merged using standardized mean differences. Statistical analyses were performed using R 4.2.3 and JAGS 4.3.0. The risk of bias was assessed using the RoB 2 tool and the certainty of findings was rated according to Grading of Recommendations Assessment, Development and Evaluation criteria. The study protocol was registered on PROSPERO (CRD42020169955).ResultsTen studies with 2483 participants were included. Concerning the primary endpoints, difelikefalin at doses of 0.25 µg/kg, 0.5 µg/kg, 1.0 µg/kg and 1.5 µg/kg, nalfurafine at 2.5 µg and 5 µg and nalbuphine at 120 mg were significantly effective in reducing itching severity compared with placebo. For the secondary endpoint, all four doses of difelikefalin were associated with higher rates of adverse events compared with placebo, while other interventions showed rates comparable to those of placebo and did not present statistically significant differences.ConclusionIn summary, difelikefalin at doses of 0.25 µg/kg and 0.5 µg/kg, along with nalfurafine at 0.25 µg/kg and 0.5 µg/kg, can be considered recommended therapeutic options for UP treatment.

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BackgroundEmergence delirium remains a major postoperative concern for children undergoing surgery. Nalbuphine is a synthetic mixed agonist-antagonist opioid, which is believed to reduce the incidence of emergence delirium in children. The primary objective was to examine the effect of nalbuphine on emergence delirium in children undergoing surgery.MethodsDatabases of MEDLINE, EMBASE, and CENTRAL were searched from their starting dates until April 2023. Randomized Clinical Trials (RCT) and observational studies comparing nalbuphine and control in children undergoing surgery were included.ResultsEight studies (n = 1466 patients) were eligible for inclusion of data analysis. Compared to the control, our pooled data showed that the nalbuphine group was associated with lower incidence of emergence delirium (RR = 0.38, 95% CI [0.30, 0.47], p ConclusionsThis review showed the administration of nalbuphine is associated with significant decrease in the incidence of emergence delirium and postoperative pain scores among children undergoing surgery. However, due to limited sample size, high degree of heterogeneity and low level of evidence, future adequately powered trials are warranted to explore the efficacy of nalbuphine on emergence delirium among the pediatric population.

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Background/Objectives: Subarachnoid anaesthesia is widely preferred for caesarean delivery due to its rapid onset, reliability, and safety. The addition of adjuvants to intrathecal hyperbaric bupivacaine has been shown to enhance the quality of anaesthesia and prolong postoperative analgesia. Opioids are among the most frequently used intrathecal adjuvants; however, their administration is associated with adverse effects. Nalbuphine, a mixed opioid agonist-antagonist, may be a promising agent for obstetric use due to its favourable pharmacodynamic properties. This study aimed to systematically review and, where feasible, meta-analyse the evidence comparing nalbuphine with other intrathecal opioid adjuvants to hyperbaric bupivacaine 0.5% for caesarean section, with a primary focus on efficacy and safety. Methods: A systematic review and meta-analysis of controlled trials was conducted. Web of Science Core Collection, MEDLINE (PubMed), Scopus, the Library of Congress, and LISTA (EBSCO) were systematically searched to identify eligible studies. Pooled mean difference (MD) and risk ratio (RR) were calculated using random-effects model. Results: Ten studies encompassing 1095 parturients were included. Compared with fentanyl, intrathecal nalbuphine was associated with a modest prolongation of effective analgesia. However, this finding was accompanied by substantial heterogeneity and very low certainty of evidence. In contrast, morphine provided a longer duration of analgesia than nalbuphine. Overall, nalbuphine and fentanyl demonstrated comparable block characteristics, with only minimal and clinically insignificant differences in onset and duration. Importantly, nalbuphine was associated with fewer adverse effects, particularly shivering and PONV. Conclusions: Subarachnoid nalbuphine may serve as a potential alternative adjuvant to 0.5% hyperbaric bupivacaine in caesarean section anaesthesia. It may provide an analgesic efficacy comparable to fentanyl and, although less potent than morphine, it may demonstrate a more favourable safety profile.

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