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BACKGROUND: Treatment with opioids is a mainstay in perioperative pain management. While the leading treatment paradigm has been procedure-specific pain management, efforts regarding personalized pain treatment are increasing. The OPIâ¢AID project aims to develop personalized algorithms for perioperative pain management, taking demographic, surgical, and anaesthesiologic factors into account. We will undertake five parallel reviews to illuminate current evidence on different aspects of individual responses to perioperative opioid treatment. METHODS: Inclusion of adult populations in English-written studies. Review-specific searches are developed for the following databases: CENTRAL, MEDLINE, Embase, clinicaltrials.gov, and clinicaltrial.eu. Two authors will independently screen citations, extract data, and assess the risks of bias in each review (QUIPS, PROBAST and RoB2, as relevant). CONCLUSION: These reviews will evaluate various aspects of perioperative opioid treatment, including individualized treatment strategies, selection of specific opioids, and individual patient responses. These will guide future development of a personalized perioperative opioid treatment algorithm (OPIâ¢AID) that will be validated and tested clinically against standard of care.
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BACKGROUND: Prolonging effects of adjuncts to local anaesthetics in peripheral nerve blocks have been demonstrated in randomised clinical trials. The chosen primary outcome and anticipated effect size have major impact on the clinical relevance of results in these trials. This scoping review aims to provide an overview of frequently used outcomes and anticipated effect sizes in randomised trials on peripheral nerve block adjuncts. METHODS: For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes. RESULTS: Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size. CONCLUSION: The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.
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INTRODUCTION: Semaglutide is increasingly used for the treatment of type 2 diabetes mellitus, overweight and other conditions. It is well known that semaglutide lowers blood glucose levels and leads to significant weight loss. Still, a systematic review has yet to investigate the adverse effects with semaglutide for all patient groups. METHODS AND ANALYSIS: We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medline, Embase, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index-Science) and clinical trial registries from their inception and onwards to identify relevant randomised clinical trials. We expect to conduct the literature search in July 2024. Two review authors will independently extract data and perform risk-of-bias assessments. We will include randomised clinical trials comparing oral or subcutaneous semaglutide versus placebo. Primary outcomes will be all-cause mortality and serious adverse events. Secondary outcomes will be myocardial infarction, stroke, all-cause hospitalisation and non-serious adverse events. Data will be synthesised by meta-analyses and trial sequential analysis; risk of bias will be assessed with Cochrane Risk of Bias tool-version 2, an eight-step procedure will be used to assess if the thresholds for statistical and clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations. ETHICS AND DISSEMINATION: This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals. PROSPERO REGISTRATION NUMBER: CRD42024499511.
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Diabetes Mellitus Tipo 2 , Peptídeos Semelhantes ao Glucagon , Hipoglicemiantes , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Humanos , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/efeitos adversos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Projetos de Pesquisa , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Many patients in the Intensive Care Unit (ICU) experience delirium. Understanding the patient perspective of delirium is important to improve care and reduce suffering. The aim of our study was to investigate the subjective patient experience of delirium, delirium-related distress, and delirium management in ICU. METHODS: Our study had a qualitative multicenter design applying individual interviews and thematic analysis. Participants were critically ill adult patients that were determined delirium positive according to validated delirium screening tools during ICU admission. The interviews were conducted after ICU discharge when patients were delirium-free as assessed by the "Rapid clinical test for delirium" (4AT) and able to participate in an interview. RESULTS: We interviewed 30 patients choosing the main themes deductively: Delirium experience; Delirium related distress; and Delirium management. Despite variations in recollection detail, ICU survivors consistently reported delirium-related distress during and after their ICU stay, manifesting as temporal confusion, misinterpretations, and a sense of distrust towards ICU staff. Delusions were characterized by a blend of factual and fictional elements. Impaired short-term memory hindered communication and intensified feelings of isolation, neglect, and loss of control. CONCLUSION: The ICU survivors in our study recalled delirium as an unpleasant and frightening experience, often leading to delirium-related distress during and after their ICU stay, indicating the necessity for enhanced assessment and treatment.
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Cuidados Críticos , Delírio , Rememoração Mental , Pesquisa Qualitativa , Humanos , Delírio/psicologia , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Cuidados Críticos/psicologia , Unidades de Terapia Intensiva , Adulto , Idoso de 80 Anos ou mais , Estado Terminal/psicologiaAssuntos
Artroplastia de Quadril , Dor Pós-Operatória , Humanos , Artroplastia de Quadril/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/prevenção & controle , Analgésicos não Narcóticos/administração & dosagem , Analgésicos não Narcóticos/uso terapêutico , Quimioterapia CombinadaRESUMO
BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly recommended for perioperative opioid-sparing multimodal analgesic treatments. Concerns regarding the potential for serious adverse events (SAEs) associated with perioperative NSAID treatment are especially relevant following gastrointestinal surgery. We assessed the risks of SAEs with perioperative NSAID treatment in patients undergoing gastrointestinal surgery. METHODS: We conducted a systematic review of randomised clinical trials assessing the harmful effects of NSAIDs versus placebo, usual care or no intervention in patients undergoing gastrointestinal surgery. The primary outcome was an incidence of SAEs. We systematically searched for eligible trials in five major databases up to January 2024. We performed risk of bias assessments to account for systematic errors, trial sequential analysis (TSA) to account for the risks of random errors, performed meta-analyses using R and used the Grading of Recommendations Assessment, Development and Evaluation framework to describe the certainty of evidence. RESULTS: We included 22 trials enrolling 1622 patients for our primary analyses. Most trials were at high risk of bias. Meta-analyses (risk ratio 0.78; 95% confidence interval [CI] 0.51-1.19; I2 = 4%; p = .24; very low certainty of evidence) and TSA indicated a lack of information on the effects of NSAIDs compared to placebo on the risks of SAEs. Post-hoc beta-binomial regression sensitivity analyses including trials with zero events showed a reduction in SAEs with NSAIDs versus placebo (odds ratio 0.73; CI 0.54-0.99; p = .042). CONCLUSION: In adult patients undergoing gastrointestinal surgery, there was insufficient information to draw firm conclusions on the effects of NSAIDs on SAEs. The certainty of the evidence was very low.
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Anti-Inflamatórios não Esteroides , Procedimentos Cirúrgicos do Sistema Digestório , Humanos , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Dor Pós-Operatória/tratamento farmacológico , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controleRESUMO
BACKGROUND: Managing postoperative pain while minimizing opioid-related adverse drug events (ORADEs) remains a significant challenge. The OPIâ¢AID Zone Tool is proposed as a novel clinical decision support tool that - both graphically and in a scoring-system - represents the relationship between pain management and the occurrence of ORADEs, aiming to enhance patient outcomes in postoperative care. The OPIâ¢AID Zone Tool places pain score on the x-axis and an ORADE score on the y-axis, and stratifies patients into five zones to reflect the composite impact of pain severity and ORADEs on the quality of postoperative patient care. The study will have two key aims: (1) to explore whether the OPIâ¢AID Zone Tool can function as a composite outcome measure for postoperative pain and ORADEs, and (2) to evaluate the use of the OPIâ¢AID Zone Tool in visual presentations and for evaluation of patients' postoperative pain management quality. METHODS: This prospective observational cohort study will include 200 adults undergoing various surgical procedures in general anesthesia with a subsequent stay in the post-anesthesia care unit (PACU) at Bispebjerg Hospital, Denmark. Substudy 1 primary outcome: To assess whether a zone score in the OPIâ¢AID Zone Tool is associated with patient-perceived health (EQ VAS), quality of recovery (QoR-PACU), and time to discharge readiness in PACU, and if the zone score has a stronger association than pain and ORADE score in themselves. Substudy 2 primary outcome: To assess how the use of intraoperative non-opioid analgesics impact where patients are placed in the OPIâ¢AID Zone Tool's XY scatterplot right after surgery. To assess if patients who receive more comprehensive non-opioid analgesic basic regimens, generally fall into lower zones. CONCLUSION: The OPIâ¢AID Zone Tool could potentially be a valuable clinical decision-making tool for optimizing postoperative care by simultaneously addressing pain management and the risk of ORADEs. By computing a composite measure of these two critical outcomes, the tool could guide more nuanced and patient-centered analgesic regimens, potentially improving patient satisfaction and operational efficiency in postoperative settings. The tool's applicability will be explored in this observational pilot and followed up in a planned series of studies (opiaid.dk).
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Analgésicos Opioides , Manejo da Dor , Dor Pós-Operatória , Humanos , Dor Pós-Operatória/tratamento farmacológico , Projetos Piloto , Estudos Prospectivos , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/administração & dosagem , Manejo da Dor/métodos , Medição da Dor/métodos , Estudos de Coortes , AdultoRESUMO
BACKGROUND: Multimodal postoperative analgesia following total hip arthroplasty is recommended, but the optimal combination of drugs remains uncertain. The aim of the RECIPE trial was to investigate the relative benefit and harm of the different combinations of paracetamol, ibuprofen, and the analgesic adjuvant dexamethasone for treatment of postoperative pain following total hip arthroplasty. METHODS: The RECIPE trial was a randomised, blinded, placebo-controlled trial conducted at nine Danish hospitals. Adults scheduled for total hip arthroplasty were randomly assigned (1:1:1:1) using a computer-generated list with stratification by site to receive combinations of oral paracetamol 1000 mg every 6 h, oral ibuprofen 400 mg every 6 h, or a single-dose of intravenous dexamethasone 24 mg in the following groups: paracetamol plus ibuprofen, ibuprofen plus dexamethasone, paracetamol plus dexamethasone, and paracetamol plus ibuprofen plus dexamethasone. The primary outcome was 24 h intravenous morphine consumption, analysed in a modified intention-to-treat population, defined as all randomly assigned participants who underwent total hip arthroplasty. The predefined minimal important difference was 8 mg. Safety outcomes included serious and non-serious adverse events within 90 days and 24 h. The trial was registered with ClinicalTrials.gov, NCT04123873. FINDINGS: Between March 5, 2020, and Nov 15, 2022, we randomly assigned 1060 participants, of whom 1043 (589 [56%] women and 454 [44%] men) were included in the modified intention-to-treat population. 261 were assigned to paracetamol plus ibuprofen, 262 to ibuprofen plus dexamethasone, 262 to paracetamol plus dexamethasone, and 258 to paracetamol plus ibuprofen plus dexamethasone. Median 24 h morphine consumption was 24 mg (IQR 12-38) in the paracetamol plus ibuprofen group, 20 mg (12-32) in the paracetamol plus dexamethasone group, 16 mg (10-30) in the ibuprofen plus dexamethasone group, and 15 mg (8-26) in the paracetamol plus ibuprofen plus dexamethasone group. The paracetamol plus ibuprofen plus dexamethasone group had a significantly reduced 24 h morphine consumption compared with paracetamol plus ibuprofen (Hodges-Lehmann median difference -6 mg [99% CI -10 to -3]; p<0·0001) and paracetamol plus dexamethasone (-4 mg [-8 to -1]; p=0·0013), however, none of the comparisons showed differences reaching the minimal important threshold of 8 mg. 91 (35%) of 258 participants in the paracetamol plus ibuprofen plus dexamethasone group had one or more adverse events, compared with 99 (38%) of 262 in the ibuprofen plus dexamethasone group, 103 (39%) of 262 in the paracetamol plus dexamethasone group, and 165 (63%) of 261 in the paracetamol plus ibuprofen group. INTERPRETATION: In adults undergoing total hip arthroplasty, a combination of paracetamol, ibuprofen, and dexamethasone had the lowest morphine consumption within 24 h following surgery and the most favourable adverse event profile, with a lower incidence of serious and non-serious adverse events (primarily driven by differences in nausea, vomiting, and dizziness) compared with paracetamol plus ibuprofen. FUNDING: The Novo Nordisk Foundation and Næstved-Slagelse-Ringsted Hospitals' Research Fund.
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Analgésicos não Narcóticos , Artroplastia de Quadril , Masculino , Adulto , Humanos , Feminino , Analgésicos não Narcóticos/uso terapêutico , Acetaminofen/uso terapêutico , Ibuprofeno/efeitos adversos , Artroplastia de Quadril/efeitos adversos , Quimioterapia Combinada , Morfina/efeitos adversos , Dexametasona/efeitos adversosRESUMO
Importance: Supplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial. Objective: To assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023. Interventions: Patients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days. Results: Of 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital. Conclusion and Relevance: In adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg. Trial Registration: ClinicalTrials.gov Identifier: NCT04425031.
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COVID-19 , Adulto , Humanos , Masculino , Idoso , Feminino , COVID-19/terapia , COVID-19/etiologia , Oxigênio , Respiração Artificial , Oxigenoterapia/métodos , Hipóxia/etiologia , Hipóxia/terapiaRESUMO
BACKGROUND: Peripheral nerve blocks may be essential elements in a multimodal pain management regime following foot and ankle surgery. We assessed the effects of ankle blocks compared with no intervention/sham block or a sciatic nerve block in patients undergoing surgery of the foot or ankle. METHODS: We searched CENTRAL, Medline, and Embase for randomised clinical trials comparing ankle block with no intervention/sham block or a sciatic nerve block for patients undergoing surgery of the foot or ankle. Our primary outcomes were duration of analgesia and cumulative 24-hour opioid consumption. We followed the recommendations of the Cochrane Handbook, and performed meta-analysis, Trial Sequential Analysis (TSA), and assessed the risk of bias and certainty of the evidence using the GRADE approach. RESULTS: We included five trials (362 participants) comparing ankle block with no intervention/sham block and three trials (247 participants) comparing ankle block with a sciatic nerve block. Ankle block may increase the duration of analgesia when compared with no intervention/sham block (MD 431 min; 96.7% CI 208 to 654), but the evidence was very uncertain. Duration was decreased when compared with a sciatic nerve block (MD -410 min; 96.7% CI -462 to -358). The ankle block duration was probably important in both comparisons. The effects on cumulative 24-hour opioid consumption were very uncertain in both comparisons. CONCLUSIONS: Ankle block may increase the duration of analgesia when compared with no intervention/sham block, but the evidence was very uncertain, and decrease the duration of analgesia when compared with a sciatic nerve block. The ankle block duration was probably clinically important in both comparisons. The effects on cumulative 24-hour opioid consumption were very uncertain.
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Tornozelo , Pé , Bloqueio Nervoso , Dor Pós-Operatória , Humanos , Bloqueio Nervoso/métodos , Tornozelo/cirurgia , Dor Pós-Operatória/prevenção & controle , Pé/cirurgia , Procedimentos Ortopédicos , Nervo Isquiático , Manejo da Dor/métodosRESUMO
BACKGROUND: Both dexamethasone and dexmedetomidine increase the duration of analgesia of peripheral nerve blocks. The authors hypothesized that combined intravenous dexamethasone and intravenous dexmedetomidine would result in a greater duration of analgesia when compared with intravenous dexamethasone alone and placebo. METHODS: The authors randomly allocated participants undergoing surgery of the foot or ankle under general anesthesia and with a combined popliteal (sciatic) and saphenous nerve block to a combination of 12 mg dexamethasone and 1 µg/kg dexmedetomidine, 12 mg dexamethasone, or placebo (saline). The primary outcome was the duration of analgesia measured as the time from block performance until the first sensation of pain in the surgical area as reported by the participant. The authors predefined a 33% difference in the duration of analgesia as clinically relevant. RESULTS: A total of 120 participants from two centers were randomized and 119 analyzed for the primary outcome. The median [interquartile range] duration of analgesia was 1,572 min [1,259 to 1,715] with combined dexamethasone and dexmedetomidine, 1,400 min [1,133 to 1,750] with dexamethasone alone, and 870 min [748 to 1,138] with placebo. Compared with placebo, the duration was greater with combined dexamethasone and dexmedetomidine (difference, 564 min; 98.33% CI, 301 to 794; P < 0.001) and with dexamethasone (difference, 489 min; 98.33% CI, 265 to 706; P < 0.001). The prolongations exceeded the authors' predefined clinically relevant difference. The duration was similar when combined dexamethasone and dexmedetomidine was compared with dexamethasone alone (difference, 61 min; 98.33% CI, -222 to 331; P = 0.614). CONCLUSIONS: Dexamethasone with or without dexmedetomidine increased the duration of analgesia in patients undergoing surgery of the foot or ankle with a popliteal (sciatic) and saphenous nerve block. Combined dexamethasone and dexmedetomidine did not increase the duration of analgesia when compared with dexamethasone.
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Tornozelo , Dexametasona , Dexmedetomidina , Pé , Bloqueio Nervoso , Humanos , Dexmedetomidina/administração & dosagem , Dexametasona/administração & dosagem , Bloqueio Nervoso/métodos , Masculino , Feminino , Pé/cirurgia , Pessoa de Meia-Idade , Tornozelo/cirurgia , Método Duplo-Cego , Quimioterapia Combinada/métodos , Idoso , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/tratamento farmacológico , Adulto , Nervo Isquiático/efeitos dos fármacosRESUMO
BACKGROUND: Morphine-sparing effects are often used to evaluate non-opioid analgesic interventions. The exact effect that would warrant the implementation of these interventions in clinical practice (a minimally important difference) remains unclear. We aimed to determine this with anchor-based methods. METHODS: This was a post hoc analysis of three studies investigating pain management after hip or knee arthroplasty (PANSAID [NCT02571361], DEX-2-TKA [NCT03506789] and Pain Map [NCT02340052]). The overall population was median aged 70, median ASA 2, 54% female. We examined the correlation between 0 and 24 h postoperative iv morphine equivalent consumption and the severity of nausea, vomiting, sedation and dizziness. The anchor was different severity degrees of these opioid-related adverse events. The primary outcome was the difference in morphine consumption between patients experiencing no versus only mild events. Secondary outcomes included the difference in morphine consumption between patients with mild versus moderate and moderate versus severe events. We used Hodges-Lehmann median differences, exact Wilcoxon-Mann-Whitney tests and quantile regression. RESULTS: The difference in iv morphine consumption was 6 mg (95% confidence interval: 4-8) between patients with no versus only mild events, 5 mg (2-8) between patients with mild versus moderate events and 0 mg (-4 to 4) between patients with moderate versus severe events. CONCLUSIONS: In populations comparable to this post-hoc analysis (orthopaedic surgery, median age 70 and ASA 2), we suggest a minimally important difference of 5 mg for 0-24 h postoperative iv morphine consumption.
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Artroplastia do Joelho , Morfina , Humanos , Feminino , Idoso , Masculino , Morfina/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Tontura/induzido quimicamente , Dor Pós-Operatória/etiologia , Analgésicos Opioides/efeitos adversos , Náusea/induzido quimicamente , Vômito/induzido quimicamente , Método Duplo-CegoRESUMO
The DEXamethasone twice for pain treatment after Total Knee Arthroplasty (DEX-2-TKA) trial showed that adding one and two doses of 24 mg intravenous dexamethasone to paracetamol, ibuprofen and local infiltration analgesia, reduced morphine consumption (primary outcome) within 48 h after TKA. We aimed to explore the differences in the effect of dexamethasone on morphine consumption in different subgroups. Quantile regression adjusted for site was used to test for significant interaction between the predefined dichotomised subgroups and treatment group. The subgroups were defined based on baseline data: sex (male/female), age (≤65 years/>65 years), American Society of Anaesthesiologists (ASA)-score (ASA I + II/III), visual analogue score of preoperative pain at rest (≤30 mm/>30 mm), pain during mobilisation (≤30 mm/>30 mm), type of anaesthesia (spinal anaesthesia/general anaesthesia and spinal converted to general anaesthesia), and prior daily use of analgesics (either paracetamol and/or NSAID/neither). These analyses were supplemented with post hoc multivariate linear regression analyses. Test of interaction comparing sex in the pairwise comparison between DX2 (dexamethasone [24 mg] + dexamethasone [24 mg]) versus placebo (p = .02), showed a larger effect of dexamethasone on morphine consumption in male patients compared to females. Test of interaction comparing age in the pairwise comparison between DX1 (dexamethasone [24 mg] + placebo) versus placebo (p = .04), showed a larger effect of dexamethasone on morphine consumption in younger patients (≤65 years) compared to older. All remaining subgroup analyses showed no evidence of a difference. The supplemental multivariate analyses did not support any significant interaction for sex (p = .256) or age (p = .730) but supported a significant interaction with the type of anaesthesia (p < .001). Our results from the quantile regression analyses indicate that the male sex and younger age (≤65 years) may be associated with a larger analgesic effect of dexamethasone than the effects in other types of patients. However, this is not supported by post-hoc multivariate linear regression analyses. The two types of analyses both supported a possible interaction with the type of anaesthesia.
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Artroplastia do Joelho , Morfina , Humanos , Masculino , Feminino , Idoso , Morfina/uso terapêutico , Acetaminofen/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Dexametasona/uso terapêutico , Analgésicos Opioides/uso terapêutico , Método Duplo-CegoRESUMO
BACKGROUND/IMPORTANCE: The effects of combining dexamethasone and dexmedetomidine on block duration are unclear. OBJECTIVE: To investigate the effects of combining dexamethasone and dexmedetomidine on block duration. EVIDENCE REVIEW: Systematic review of randomized controlled trials (RCTs) from Medline, Embase, CENTRAL, CINAHL, the Web of Science, and BIOSIS until June 8, 2023. RCTs with adults undergoing surgery with a peripheral nerve block randomized to combined dexamethasone and dexmedetomidine versus placebo or other adjuncts were eligible. Primary outcome was duration of analgesia. We performed meta-analysis, trial sequential analysis, risk of bias-2, and Grading Recommendations Assessment, Development, and Evaluation assessment. FINDINGS: We included 9 RCTs with 14 eligible comparisons. The combination of dexamethasone and dexmedetomidine was compared with placebo in three RCTs (173 participants), dexamethasone in seven (569 participants), and dexmedetomidine in four (281 participants). The duration of analgesia was likely increased with the combination versus placebo (mean difference 460 min, 95% CI 249 to 671) and versus dexmedetomidine (mean difference 388 min, 95% CI 211 to 565). The duration was likely similar with the combination versus dexamethasone (mean difference 50 min, 95% CI -140 to 239). The certainty of the evidence was moderate because most trials were at high risk of bias. CONCLUSIONS: Combined dexamethasone and dexmedetomidine likely increased the duration of analgesia when compared with placebo and dexmedetomidine. The combination likely provided a similar duration of analgesia as dexamethasone. Based on this systematic review, it seems reasonable to use dexamethasone as the sole adjunct if the goal is to increase the duration of analgesia.
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PURPOSE: We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo. METHODS: We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values. RESULTS: At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS. CONCLUSIONS: In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.
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Delírio , Haloperidol , Adulto , Humanos , Delírio/tratamento farmacológico , Haloperidol/uso terapêutico , Hospitalização , Unidades de Terapia Intensiva , Qualidade de VidaRESUMO
INTRODUCTION: Outpatient (OPT) thyroid surgery is increasing, with patient selection being pivotal for safety. While numerous studies exist, most are retrospective and encompass both benign and malignant cases. METHODS: We conducted a randomised clinical trial on patients undergoing hemithyroidectomy for benign thyroid disease. Participants were assigned to OPT or inpatient groups. We collected data on complications, failure to discharge on surgery day, post-operative pain, nausea, sleep quality and patient satisfaction. RESULTS: Among 97 patients, 27.5% (14/51) in the OPT group could not be discharged on the day of surgery due to minor complications, primarily nausea (36%) and neck swelling (29%). No reoperations were needed. Though OPT patients exhibited a higher rate of minor complications (29%), they reported less post-operative nausea, better sleep and a faster return to normal activity. CONCLUSIONS: Discharge on the day of surgery is not always possible with OPT thyroid surgery. However, our findings suggest that OPT hemithyroidectomy for benign cases can be both safe and feasible for a selected group of patients. FUNDING: None TRIAL REGISTRATION. CLINICALTRIALS: gov Identifier: NCT02891252.