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American Journal of Clinical Dermatology Jan 2024Chronic prurigo (CPG) is a neuroinflammatory, fibrotic dermatosis that is defined by the presence of chronic pruritus (itch lasting longer than 6 weeks),... (Review)
Review
Chronic prurigo (CPG) is a neuroinflammatory, fibrotic dermatosis that is defined by the presence of chronic pruritus (itch lasting longer than 6 weeks), scratch-associated pruriginous skin lesions and history of repeated scratching. Patients with CPG experience a significant psychological burden and a notable impairment in their quality of life. Chronic prurigo of nodular type (CNPG; synonym: prurigo nodularis) represents the most common subtype of CPG. As CNPG is representative for all CPG subtypes, we refer in this review to both CNPG and CPG. We provide an overview of the clinical characteristics and assessment of CPG, the burden of disease and the underlying pathophysiology including associated therapeutic targets. The information provided results from a PubMed search for the latest publications and a database search for current clinical trials (ClinicalTrials.gov, EU Clinical Trials Register [European Medicines Agency]; using the following terms or combinations of terms: 'chronic prurigo', 'prurigo', 'prurigo nodularis', 'pathophysiology', 'therapy', 'biologics', 'treatment'). Dupilumab is the first authorized systemic therapy by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for CNPG to date. Topical and systemic agents that are currently under investigation in clinical randomized, placebo-controlled phase II and III trials such as biologics (e.g., nemolizumab, vixarelimab/KPL-716, barzolvolimab/CDX-0159), small molecules (ruxolitinib cream, povorcitinib/INCB054707, abrocitinib) and the opioid modulator nalbuphine are highlighted. In the last past 15 years, several milestones have been reached regarding the disease understanding of CPG such as first transcriptomic analysis, first terminology, first guideline, and first therapy approval in 2022, which contributed to improved medical care of affected patients. The broad range of identified targets, current case observations and initiated trials offers the possibility of more drug approvals in the near future.
Topics: Humans; Prurigo; Quality of Life; Pruritus; Antibodies, Monoclonal; Chronic Disease
PubMed: 37717255
DOI: 10.1007/s40257-023-00818-z -
Veterinaria Italiana Dec 2022This study describes the selected pharmacodynamics and pharmacokinetics of nalbuphine (NAL) in xylazine (XYL)‑sedated horses. Five adult healthy horses were randomly...
This study describes the selected pharmacodynamics and pharmacokinetics of nalbuphine (NAL) in xylazine (XYL)‑sedated horses. Five adult healthy horses were randomly received 2 treatments at a 1‑week interval; XYL treatment (0.55 mg/kg IV) and XYL/NAL treatment (XYL, 0.55 mg/kg IV; NAL, 0.3 mg/kg IV). The measured pharmacodynamic variables were sedative and analgesic effects and the effect on ataxia and some physiological parameters. for the pharmacokinetics of NAL, its plasma concentrations were measured using HPLC and a 2‑compartment analysis was performed. Greater and prolonged sedation was evident after XYL/NAL treatment compared with XYL treatment. Slightly improved and prolonged analgesia was demonstrated after XYL/NAL treatment. Significant changes in blood pressure and respiratory rate lasted for a shorter duration with XYL/NAL treatment than with XYL treatment. After XYL treatment, rectal temperature was significantly different from baseline and XYL/NAL treatment. Elimination half‑life of NAL was 3.47 ± 1.39 hours and total body clearance was 2.88 ± 0.73 L/kg/hour. In conclusion, addition of NAL to XYL resulted in remarkable advantages on the measured parameters. The obtained pharmacokinetics of NAL could be useful in determining the effective NAL infusion rate, which could be further evaluated as an adjunctive agent to XYL for prolonged sedation in horses.
Topics: Animals; Horses; Xylazine; Nalbuphine
PubMed: 37219832
DOI: 10.12834/VetIt.2408.16506.1 -
Pain Research & Management 2022The study was to assess the efficacy and safety of nalbuphine combined with dexmedetomidine for preventive analgesia in endoscopic sinus surgery. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The study was to assess the efficacy and safety of nalbuphine combined with dexmedetomidine for preventive analgesia in endoscopic sinus surgery.
METHODS
110 patients with deviation of the nasal septum were randomized into the nalbuphine group (group N), dexmedetomidine combined with nalbuphine group (group DN), and saline group (group C). Fifteen minutes before the induction of anesthesia, patients in group N were injected nalbuphine 0.2 mg/kg intravenously; patients in group DN received intravenous infusion of dexmedetomidine 0.5 g/kg and injection of nalbuphine 0.2 mg/kg; patients in group C received 0.9% saline. Mean arterial pressure (MAP), heart rate (HR), numerical rating scale (NRS) scores, quality of recovery-40 (QoR-40) scores, the need for remedial analgesia, the consumption of remifentanil and propofol, and the incidence of adverse reactions were recorded.
RESULTS
MAP, HR, and NRS scores of the DN group were significantly lower and the QoR-40 scores were higher than those of groups N and C ( < 0.001). The need for remedial analgesia, the consumption of remifentanil and propofol, and the incidence of nausea in the DN group were the lowest among the three groups ( < 0.001).
CONCLUSION
Preventive analgesia with nalbuphine and dexmedetomidine in endoscopic sinus surgery can not only maintain hemodynamic stability but also reduce intraoperative anesthetic dosage, postoperative pain, and improve the quality of postoperative recovery without affecting the revival and extubation time.
Topics: Analgesia; Dexmedetomidine; Double-Blind Method; Humans; Nalbuphine; Piperidines; Propofol; Remifentanil
PubMed: 35685676
DOI: 10.1155/2022/2344733 -
Cureus Dec 2021Objectives In this study, our primary aim was to compare the efficacy of and haemodynamic changes related to nalbuphine and tramadol when used for the control of...
Objectives In this study, our primary aim was to compare the efficacy of and haemodynamic changes related to nalbuphine and tramadol when used for the control of post-spinal anaesthesia shivering, as per Wrench shivering grades. The secondary aim was to study the complications and adverse effects associated with the drugs. Methodology A total of 60 patients with the American Society of Anesthesiologists (ASA) physical status class I/II who were scheduled to undergo elective surgeries under spinal anaesthesia were divided into two groups of 30 each. Group N received intravenous nalbuphine 0.05 mg/kg and Group T received intravenous tramadol 1 mg/kg, two minutes after the patients started shivering after undergoing spinal anaesthesia. The anaesthesia technique was standardised for all the patients in the study. The shivering grade was measured using the Wrench shivering grade and the level of sedation was studied using the Ramsay Sedation Scale. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded. All the parameters were measured at the baseline and at one, two, five, 10, 15, and 30 minutes after administering the drug. Results Immediately after giving the drug, the time taken to control shivering was significantly lower in Group T: 3.633 minutes. However both the drugs controlled shivering effectively. There were no significant haemodynamic changes in both groups, probably due to the lower dosage of drugs used in our study. A different set of side effects were seen in each group. In Group N, out of 30 patients, five (16.67%) patients were sedated, four (13.33%) had hypotension, and two (6.67%) had bradycardia, whereas In Group T, out of 30 patients, five (16.67%) patients had nausea, four (13.33%) had nausea and vomiting, and two (16.67%) had dizziness following the administration of the drug. Respiratory depression or itching was not seen in any patients in either group. Conclusion Based on our findings, both Intravenous nalbuphine 0.05 mg/kg and intravenous tramadol 1 mg/kg are effective in treating patients with post-spinal anaesthesia shivering; however, the time taken to control shivering is lower with tramadol than nalbuphine. Both the drugs resulted in minimal haemodynamic changes and adverse effects.
PubMed: 35070534
DOI: 10.7759/cureus.20481 -
Cureus May 2021Background In this study, our primary aim was to compare the efficacy of fentanyl and nalbuphine in attenuating the pressor response to laryngoscopy and tracheal...
Background In this study, our primary aim was to compare the efficacy of fentanyl and nalbuphine in attenuating the pressor response to laryngoscopy and tracheal intubation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The secondary aim was to observe hemodynamic response to pneumoperitoneum and to study the level of sedation using the Richmond Agitation-Sedation Scale (RASS). Methodology A total of 180 patients belonging to the American Society of Anesthesiologist Physical Status class I/II scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia were divided into two groups of 90 each. group A received intravenous nalbuphine 0.2 mg/kg and group B received intravenous fentanyl 2 μg/kg, five minutes before induction of anesthesia. Technique of anesthesia was standardized for all patients in the study. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before giving the study drug; before induction; immediately after intubation; at one, three, and five minutes after intubation; before creating pneumoperitoneum; 15 minutes after creating pneumoperitoneum; and five minutes after release of pneumoperitoneum. Preoperative and postoperative sedation scoring was done using RASS. Results Immediately after intubation, HR was significantly higher in group A (p = 0.016). Both groups showed a rise in SBP immediately after intubation. Group A showed a significantly higher SBP in comparison to group B (135.97 ± 13.02 vs. 130.04 ± 13.33; p = 0.003). The DBP and MAP showed a similar trend. At one, three, and five minutes after intubation, HR, SBP, DBP, and MAP were similar between the groups. Post-extubation sedation score was significantly higher in group A (p < 0.0001). Conclusions We found that fentanyl was more effective than nalbuphine in attenuating the pressor response to laryngoscopy and tracheal intubation in patients undergoing laparoscopic cholecystectomy under general anesthesia. There was no significant difference observed between nalbuphine and fentanyl in the hemodynamic response to pneumoperitoneum. The depth of sedation post-extubation was significantly greater with nalbuphine.
PubMed: 34178483
DOI: 10.7759/cureus.15142 -
Archives of Disease in Childhood Jan 2023Intranasal nalbuphine could be a safe, efficacious and non-invasive alternative to parenteral pain medication in infants. We aimed to assess pharmacokinetics (PK) and... (Clinical Trial)
Clinical Trial
OBJECTIVES
Intranasal nalbuphine could be a safe, efficacious and non-invasive alternative to parenteral pain medication in infants. We aimed to assess pharmacokinetics (PK) and tolerability of intranasal and intravenous nalbuphine administration in infants.
METHODS
Prospective open-label study including infants 1-3 months of age admitted to the emergency department, receiving nalbuphine for procedural pain management. Patients were alternately allocated to a single nalbuphine dose of 0.05 mg/kg intravenously or 0.1 mg/kg intranasally. Nalbuphine PK samples were collected 15, 30 and 120-180 min after dosing. Area under the concentration time curve (AUC) was calculated by non-compartmental analysis (NCA) and compared by Wilcoxon test. Neonatal Infant Pain Score was assessed during nalbuphine administration and the following interventions: venous access, urinary catheterisation, lumbar puncture.
RESULTS
Out of 52 study subjects receiving nalbuphine, 31 were eligible for NCA (11 intravenous, 20 intranasal). Median AUC after 0.05 mg/kg intravenously was 8.7 (IQR: 8.0-18.6) µg×L/hour vs 7.6 (5.4-10.4) µg×L/hour after intranasal administration of 0.1 mg/kg (p=0.091). Maximum serum concentration (C) was observed 30 min after intranasal administration (3.5-5.6 µg/L). During intravenous and intranasal nalbuphine administration, mild to no pain was recorded in 71% and 67% of study subjects, respectively.
CONCLUSION
This is the first study investigating intranasal administration of nalbuphine in infants suggesting an intranasal bioavailability close to 50%. Non-invasive intranasal application was well tolerated. Additional studies are warranted to optimise dosing and timing of interventions as C is delayed by half an hour after intranasal administration.
TRIAL REGISTRATION NUMBER
NCT03059511.
Topics: Humans; Infant; Administration, Intranasal; Administration, Intravenous; Biological Availability; Nalbuphine; Pain; Prospective Studies
PubMed: 36100355
DOI: 10.1136/archdischild-2022-323807 -
Frontiers in Pediatrics 2023Anesthetics such as propofol, esketamine and nalbuphine are used during the upper gastrointestinal endoscopy to achieve and maintain the desired sedation level. The aim...
Efficacy and safety comparison of esketamine-propofol with nalbuphine-propofol for upper gastrointestinal endoscopy in children: a multi-center randomized controlled trial.
BACKGROUND AND AIMS
Anesthetics such as propofol, esketamine and nalbuphine are used during the upper gastrointestinal endoscopy to achieve and maintain the desired sedation level. The aim of the study was to evaluate the effectiveness and safety of propofol-nalbuphine and propofol-esketamine in children.
METHODS
A multi-centered study was performed at three tertiary class-A hospitals. Children between 3 and 12 years old undergoing diagnostic painless upper gastrointestinal endoscopy were included and randomly divided into esketamine or nalbuphine group to estimate the primary outcome of successful endoscope insertion. The patients were given esketamine 0.5 mg/kg and propofol 2 mg/kg intravenously in esketamine group, with nalbuphine 0.2 mg/kg and propofol 2 mg/kg in the nalbuphine group. The primary outcome was success rate for the first attempt of endoscope insertion in each group. Secondary outcomes included the safety of both anesthesia regimens and gastroenterologist's satisfaction. We used the Face, Leg, Activity, Cry and Consolability (FLACC) scale to evaluate the level of pain before and during the procedure and the Pediatric Anesthesia Emergence Delirium (PAED) scale to assess the level of agitation and delirium after awakening from anesthesia.
RESULTS
Among 246 patients, 200 were randomly included in the final intention-to-treat analysis, with 100 patients in each group. The success rate for the first attempt of endoscope insertion in the esketamine group was higher than the nalbuphine group (97% vs. 66%; < 0.01). The heart rate and mean arterial pressure after intraoperative administration in the esketamine group were higher than those in the nalbuphine group, while the delirium incidence during awakening was higher in esketamine group (all < 0.05).
CONCLUSION
The success rate for the first attempt of endoscope insertion of children undergoing upper gastrointestinal endoscopy in the esketamine group was higher than the nalbuphine group, propofol-related hemodynamic changes were reduced accordingly, while the incidence of esketamine-related adverse effects could be high.
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2000040500.
PubMed: 37441574
DOI: 10.3389/fped.2023.1126522