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Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts.

ABSTRACT: Procedural sedation and analgesia (PSA) is important during painful dilatation and stenting in patients undergoing percutaneous trans-hepatic biliary drainage (PTBD). A prospective, nonblinded randomized clinical trial was performed comparing different analgesic regimens with regard to the patient's comfort. Patients were randomly assigned to two treatment groups in a parallel study, receiving either remifentanil or combined midazolam, piritramide, and S-ketamine. The primary study endpoint was pain intensity before, during, and after the intervention using the numerical rating scale (0, no pain; 10, maximum pain). The secondary study endpoint was the satisfaction of the interventional radiologist. Fifty patients underwent PTBD of whom 19 (38.0%) underwent additional stenting. During intervention, the two groups did not differ significantly. After the intervention, the need for auxiliary opioids was higher (12.5% vs 7.7%; p = 0.571) and nausea/vomiting was more frequently observed (33.4% vs 3.8%; p = 0.007) in patients with remifentanil than in patients with PSA. Overall, 45 patients (90.0%) needed additional administration of non-opioid analgesics during postinterventional observation. Remifentanil and combined midazolam, piritramide, and S-ketamine obtained adequate analgesic effects during PTBD. After the intervention, medications with antiemetics and long-acting analgesics were more frequently administered in patients treated with remifentanil (EudraCT No. 2006-003285-34; institutional funding).

SUBMITTER: Zanvettor A

PROVIDER: S-EPMC7712221 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts.

Zanvettor Alex A Lederer Wolfgang W Glodny Bernhard B Chemelli Andreas P AP Wiedermann Franz J FJ

Open medicine (Warsaw, Poland) 20200828 1

Procedural sedation and analgesia (PSA) is important during painful dilatation and stenting in patients undergoing percutaneous trans-hepatic biliary drainage (PTBD). A prospective, nonblinded randomized clinical trial was performed comparing different analgesic regimens with regard to the patient's comfort. Patients were randomly assigned to two treatment groups in a parallel study, receiving either remifentanil or combined midazolam, piritramide, and S-ketamine. The primary study endpoint was ...[more]

PMID: 33336039

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Project description:Background and study aims Endoscopic ultrasound-guided intrahepatic biliary drainage (EUS-IBD) struggles to find a place in management algorithms, especially compared to percutaneous drainage (PTBD). In the setting of hilar stenoses or postsurgical anatomy data are even more limited. Patients and methods All consecutive EUS-IBDs performed in our tertiary referral center between 2012 - 2019 were retrospectively evaluated. Rendez-vous (RVs), antegrade stenting (AS) and hepatico-gastrostomies (HGs) were compared. The predefined subgroup of EUS-IBD patients with proximal stenosis/surgically-altered anatomy was matched 1:1 with PTBD performed for the same indications. Efficacy, safety and events during follow-up were compared. Results One hundred four EUS-IBDs were included (malignancies = 87.7 %). These consisted of 16 RVs, 43 ASs and 45 HGs. Technical and clinical success rates were 89.4 % and 96.2 %, respectively. Any-degree, severe and fatal adverse events (AEs) occurred in 23.3 %, 2.9 %, and 0.9 % respectively. Benign indications were more common among RVs while proximal stenoses, surgically-altered anatomy, and disconnected left ductal system among HGs. Procedures were shorter with HGs performed with specifically designed stents (25 vs . 48 minutes, P = 0.004) and there was also a trend toward less dysfunction with those stents (6.7 % vs . 30 %, P = 0.09) compared with previous approaches. Among patients with proximal stenosis/surgically-altered anatomy, EUS-IBD vs. PTBD showed higher rates of clinical success (97.4 % vs. 79.5 %, P = 0.01), reduced post-procedural pain (17.8 % vs. 44.4 %, p = 0.004), shorter median hospital stay (7.5 vs 11.5 days, P = 0.01), lower rates of stent dysfunction (15.8 % vs. 42.9 %, P = 0.01), and the mean number of reinterventions was lower (0.4 vs. 2.8, P < 0.0001). Conclusions EUS-IBD has high technical and clinical success with an acceptable safety profile. HGs show comparable outcomes, which are likely to further improve with dedicated tools. For proximal strictures and surgically-altered anatomy, EUS-IBD seems superior to PTBD.

Project description:BackgroundProcedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO(2)] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes.Methods/designElectronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable.DiscussionThis review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.Systematic review registrationPROSPERO CRD42015017251.

Project description:Background and study aims Preoperative biliary drainage of hilar cholangiocarcinoma (HC) is controversial. The goal of this study was to compare the clinical outcome and associated complications for types II, III, and IV HC managed by percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP). Patients and methods Between January 2011 and June 2017, a total of 180 patients with II, III, and IV HC were enrolled in this retrospective cohort study. According to the drainage method, patients were divided into two groups: PTBD (n = 81) and ERCP (n = 99). This study was registered with ClinicalTrials.gov, NCT03104582, and was completed. Results Compared with the PTBD group, the ERCP group had a higher incidence of post-procedural cholangitis (37 [37.37 %] vs. 18 [22.22 %], P = 0.028) and pancreatitis (17 [17.17 %] vs. 2 [2.47 %], P = 0.001); required more salvaged biliary drainage (18 [18.18 %] vs. 5 [6.17 %], P = 0.029), and incurred a higher cost ( P < 0.05). Patients with type III and IV HC in the ERCP group had more cholangitis than those in the PTBD group (26 [36.62 %] vs. 11 [18.03 %], P = 0.018). The rate of cholangitis in patients who received endoscopic bilateral biliary stents insertion was higher than patients with unilateral stenting (23 [50.00 %] vs. 9 [26.47 %], P = 0.034), and underwent PTBD internal-external drainage had a higher incidence of cholangitis than those with only external drainage (11 [34.36 %] vs. 7 [14.29 %], P = 0.034). No significant difference in the rate of cholangitis was observed between the endoscopic unilateral stenting group and the endoscopic nasobiliary drainage group (9 [26.47 %] vs. 5 [26.32 %], P = 0.990). Conclusion Compared to ERCP, PTBD reduced the rate of cholangitis, pancreatitis, salvage biliary drainage, and decreased hospitalization costs in patients with types II, III, and IV HC. Risk of cholangitis for patients with types III and IV was significantly lower in the PTBD group.

Project description:Procedural sedation and analgesia outside the operating theater have become standard care in managing pain and anxiety in children undergoing diagnostic and therapeutic procedures. The objectives of this study are to describe the current pediatric procedural sedation and analgesia practice patterns in European emergency departments, to perform a needs assessment-like analysis, and to identify barriers to implementation. A survey study of European emergency departments treating children was conducted. Through a lead research coordinator identified through the Research in European Pediatric Emergency Medicine (REPEM) network for each of the participating countries, a 30-question questionnaire was sent, targeting senior physicians at each site. Descriptive statistics were performed. One hundred and seventy-one sites participated, treating approximately 5 million children/year and representing 19 countries, with a response rate of 89%. Of the procedural sedation and analgesia medications, midazolam (100%) and ketamine (91%) were available to most children, whereas propofol (67%), nitrous oxide (56%), intranasal fentanyl (47%), and chloral hydrate (42%) were less frequent. Children were sedated by general pediatricians in 82% of cases. Safety and monitoring guidelines were common (74%), but pre-procedural checklists (51%) and capnography (46%) less available. In 37% of the sites, the entire staff performing procedural sedation and analgesia were certified in pediatric advanced life support. Pediatric emergency medicine was a board-certified specialty in 3/19 countries. Physician (73%) and nursing (72%) shortages and lack of physical space (69%) were commonly reported as barriers to procedural sedation and analgesia. Nurse-directed triage protocols were in place in 52% of the sites, mostly for paracetamol (99%) and ibuprofen (91%). Tissue adhesive for laceration repair was available to 91% of children, while topical anesthetics for intravenous catheterization was available to 55%. Access to child life specialists (13%) and hypnosis (12%) was rare.Conclusion: Procedural sedation and analgesia are prevalent in European emergency departments, but some sedation agents and topical anesthetics are not widely available. Guidelines are common but further safety nets, nurse-directed triage analgesia, and nonpharmacologic support to procedural sedation and analgesia are lacking. Barriers to implementation include availability of sedation agents, staff shortage, and lack of space. What is Known: • Effective and prompt analgesia, anxiolysis, and sedation (PSA) outside the operating theatre have become standard in managing pain and anxiety in children undergoing painful or anxiogenic diagnostic and therapeutic procedures. • We searched PubMed up to September 15, 2020, without any date limits or language restrictions, using different combinations of the MeSH terms "pediatrics," "hypnotics and sedatives," "conscious sedation," and "ambulatory surgical procedures" and the non-MeSH term "procedural sedation" and found no reports describing the current practice of pediatric PSA in Europe. What is New: • This study is, to the best of our knowledge, the first to shed light on the pediatric PSA practice in European EDs and uncovers important gaps in several domains, notably availability of sedation medications and topical anesthetics, safety aspects such as PSA provider training, availability of nonpharmacologic support to PSA, and high impact interventions such as nurse-directed triage analgesia. • Other identified barriers to PSA implementation include staff shortage, control of sedation medications by specialists outside the emergency department, and lack of space.

Dataset Information

Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts.

Publications

Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts.

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