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OBJECTIVE: This study aimed to evaluate the safety and feasibility of intranasal administration of dexmedetomidine as a premedication for preventing hypotension and hypothermia in canine patients undergoing MRI examinations. ANIMALS: Dogs undergoing MRI examinations for neurological disorders were enrolled in this study. The dogs were randomly assigned: 15 to the N-Dex group (without premedication) and 13 to the Dex group (125 µg/m2 of dexmedetomidine, intranasally, as a premedication). METHODS: During the examination, pulse rate, systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure were recorded every 5 minutes for the first 30 minutes. Body temperature was measured before and after the examination. Any adverse events during the procedure were documented. RESULTS: Significant changes in pulse rate during the examination were not distinguishable. Although blood pressure and body temperature decreased in both groups under anesthesia, dogs in the Dex group had a significantly smaller drop in blood pressure and body temperature and fewer hypotension events than those in the N-Dex group MRI examinations of 1 hour's duration. Two dogs in the Dex group exhibited bradycardia at 45 and 60 minutes of MRI examination, which resolved after receiving atipamezole. CLINICAL RELEVANCE: Our results indicate that intranasal administration of 125 µg/m2 of dexmedetomidine as premedication is safe and can potentially mitigate hypothermia and hypotension in dogs with neurological disorders during MRI examinations.
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Dexmedetomidina , Enfermedades de los Perros , Hipnóticos y Sedantes , Hipotensión , Hipotermia , Enfermedades del Sistema Nervioso , Animales , Perros , Administración Intranasal/veterinaria , Dexmedetomidina/administración & dosificación , Dexmedetomidina/efectos adversos , Enfermedades de los Perros/inducido químicamente , Enfermedades de los Perros/diagnóstico por imagen , Hipnóticos y Sedantes/administración & dosificación , Hipnóticos y Sedantes/efectos adversos , Hipotensión/prevención & control , Hipotensión/veterinaria , Hipotermia/prevención & control , Hipotermia/veterinaria , Imagen por Resonancia Magnética/efectos adversos , Imagen por Resonancia Magnética/veterinaria , Enfermedades del Sistema Nervioso/diagnóstico por imagen , Enfermedades del Sistema Nervioso/veterinaria , Premedicación/efectos adversos , Premedicación/métodos , Premedicación/veterinaria , Estudios de FactibilidadRESUMEN
PURPOSE: Paclitaxel is associated with hypersensitivity reactions (HSRs). Intravenous premedication regimens have been devised to decrease the incidence and severity of HSRs. At our institution oral histamine 1 receptor antagonists (H1RA) and histamine 2 receptor antagonists (H2RA) were adopted as standard. Standardizations were implemented for consistent premedication use in all disease states. The purpose of this retrospective study was to compare the incidence and severity of HSRs before and after standardization. METHODS: Patients who received paclitaxel from 20 April 2018 to 8 December 2020 having an HSR were included in analysis. An infusion was flagged for review if a rescue medication was administered after the start of the paclitaxel infusion. The incidences of all HSR prior to and post-standardization were compared. A subgroup analysis of patients receiving paclitaxel for the first and second time was performed. RESULTS: There were 3499infusions in the pre-standardization group and 1159infusions in the post-standardization group. After review, 100 HSRs pre-standardization and 38 HSRs post-standardization were confirmed reactions. The rate of overall HSRs was 2.9% in the pre-standardization group and 3.3% in the post-standardization group (p = 0.48). HSRs, during the first and second doses of paclitaxel, occurred in 10.2% of the pre-standardization and 8.5% of the post-standardization group (p = 0.55). CONCLUSIONS: This retrospective interventional study demonstrated that same-day intravenous dexamethasone, oral H1RA, and oral H2RA are safe premedication regimens for paclitaxel. No change in the severity of reactions was seen. Overall, better adherence to premedication administration was seen post-standardization.
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Antineoplásicos Fitogénicos , Hipersensibilidad a las Drogas , Antagonistas de los Receptores Histamínicos H1 , Antagonistas de los Receptores H2 de la Histamina , Paclitaxel , Humanos , Dexametasona/uso terapéutico , Hipersensibilidad a las Drogas/epidemiología , Hipersensibilidad a las Drogas/prevención & control , Hipersensibilidad a las Drogas/tratamiento farmacológico , Histamina , Antagonistas de los Receptores Histamínicos H1/administración & dosificación , Paclitaxel/uso terapéutico , Premedicación/efectos adversos , Estudios Retrospectivos , Antagonistas de los Receptores H2 de la Histamina/administración & dosificaciónRESUMEN
BACKGROUND: Children with a history of allergic transfusion reactions (ATRs) receive antihistamine premedication with or without hydrocortisone to prevent subsequent reactions. We aim to examine the frequency of developing ATRs to subsequent different blood product type transfusions. METHODS: A retrospective chart review of children who received blood product transfusions (packed red blood cells, platelets, frozen plasma, intravenous immunoglobin, albumin, and cryoprecipitate) and developed ATRs. Cases were identified through Transfusion Transmitted Injuries Surveillance System- Ontario database with a complementary chart review. Demographics and subsequent transfusions records were described. RESULTS: During this period, 35,925 blood products were transfused to 4153 patients. Thirty-eight ATRs were reported in 30 patients. All ATRs were minor except 1 anaphylaxis to albumin transfusion. Seven patients (23%) developed multiple ATRs, and all of them were of the same blood product type. A total of 60 subsequent different blood product types were transfused to the 7 patients who had multiple ATRs; none of those transfusions caused ATR. CONCLUSION: In children with a history of ATR, developing a reaction to a different blood product type is rare. Hence, premedicating those transfusions is not warranted.
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Anafilaxia , Reacción a la Transfusión , Humanos , Niño , Estudios Retrospectivos , Reacción a la Transfusión/epidemiología , Reacción a la Transfusión/etiología , Reacción a la Transfusión/prevención & control , Transfusión Sanguínea , Anafilaxia/epidemiología , Anafilaxia/etiología , Anafilaxia/prevención & control , Premedicación/efectos adversos , Transfusión de PlaquetasRESUMEN
OBJECTIVE: The aim was to evaluate the effect of oral administration of preoperative duloxetine on postoperative pain and total analgesic requirement in the postoperative period as the primary objective. The secondary objective was to evaluate the perioperative hemodynamic parameters, sedation scores, demographic data, and incidence of side effects (if any) in patients undergoing laparoscopic cholecystectomy. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled study conducted in a tertiary level medical college on 60 patients of either sex posted for laparoscopic cholecystectomies with American Society of Anesthesiologists (ASA) I and II. The patients were divided into 2 groups (n=30), the patients were given duloxetine 60 mg capsules and placebo capsules (Becosules) 2 hours before surgery. RESULTS: The total requirement for both first and second rescue analgesics was higher in placebo as compared with duloxetine and was found to be significant ( P <0.05). The difference in mean visual analog scale score was significantly ( P <0.001) higher in placebo as compared with duloxetine at all-time intervals postoperatively 0 minute (7.6±0.7 vs. 4.6±0.8); 15 minutes (5.9±0.8 vs. 4.2±1.0); 30 minutes (4.4±0.5 vs. 3.6±0.9); 4 hours (6.6±0.06 vs. 5.3±1.3); 8 hours (5.2±1.2 vs. 3.9±1.0); and 12 hours (5.1±1.3 vs. 2.3±0.7). The mean arterial blood pressure and heart rate were significantly higher in placebo compared with duloxetine in most of the time intervals in the perioperative period. There was no significant difference in the sedation score between the groups except the 30 minutes and 8 hours postoperative. DISCUSSION: Preoperative oral duloxetine during laparoscopic cholecystectomy could reduce postoperative pain, postoperative analgesic requirements, and better optimization of hemodynamics without causing major side effects.
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Colecistectomía Laparoscópica , Analgésicos , Colecistectomía Laparoscópica/efectos adversos , Método Doble Ciego , Clorhidrato de Duloxetina , Humanos , Dimensión del Dolor , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Periodo Posoperatorio , Premedicación/efectos adversos , Estudios ProspectivosRESUMEN
AIMS: The aim of this study is to investigate the rates of hypersensitivity reactions (HSRs) in patients receiving paclitaxel chemotherapy, with and without a histamine-2 (H2 ) antagonists. METHOD: This prospective, multi-centre, cohort study compared patients receiving paclitaxel treated with premedication regimens containing chlorphenamine, dexamethasone and an H2 antagonist vs patients treated without an H2 antagonist. Rates of HSRs were described and logistic multivariable regression was used to investigate any associations with H2 antagonist treatment, adjusting for confounding variables. RESULTS: A total of 1043 individuals were included in the study; of these, 638 (61%) patients received an H2 antagonist and 405 (49%) were not given an H2 antagonist. Incidence of HSR in the cohort treated with H2 antagonists was 11.31% (n = 70) vs 9.86% (n = 41) in the cohort without. There was no statistically significant difference between the rates of HSR observed in those receiving and not receiving an H2 antagonist (odds ratio 1.04, 95% CI 0.65, 1.66, P = .9). CONCLUSIONS: Results presented within the study are consistent with other recently published evidence to suggest that H2 antagonists do not confer any advantage as part of premedication regimens in reducing the incidence of HSR in patients treated with paclitaxel.
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Antineoplásicos Fitogénicos , Hipersensibilidad a las Drogas , Antineoplásicos Fitogénicos/efectos adversos , Estudios de Cohortes , Dexametasona/uso terapéutico , Hipersensibilidad a las Drogas/etiología , Histamina , Antagonistas de los Receptores Histamínicos H1/efectos adversos , Antagonistas de los Receptores H2 de la Histamina/uso terapéutico , Humanos , Paclitaxel/efectos adversos , Premedicación/efectos adversos , Premedicación/métodos , Estudios ProspectivosRESUMEN
OBJECTIVE: To study the efficacy of the prevention of immediate hypersensitivity reactions (HSRs) from omitting ranitidine in the premedication protocol in patients who had chemotherapy with taxane regimen. METHODS: This was a Multicenter, Ambispective Non-Randomized Historical Controlled Cohort Study. The incidence of HSRs in the patients who had the modified premedication without ranitidine were collected to compare with the historical group who had the standard premedication protocol with ranitidine. The relationships of each HSRs in the experimental group were compared with the historical control group using a multilevel regression analysis with the random-effects model. RESULT: A total of 441 patients were enrolled and analyzed in this study. 221 patients received the modified premedication protocol compared with 220 patients who received the standard premedication protocol in the historical group. HSRs were observed in 6 of 768 cycles of chemotherapy (0.78%) in a group of patients with the modified premedication protocol. Moreover, it was found in 4 of 761 cycles of chemotherapy (0.52%) in a group of patients with the standard premedication protocol. When comparing the relationship of the HSRs incidence between the groups using multilevel regression analysis with the random-effects model, there were no differences with a statistical significance (regression coefficients = 0.008, p-value = 0.30). CONCLUSION: The results of the study comprised evidence-based medicine supporting the safety of omitting ranitidine from the premedication protocol for the patients who had a taxane regimen and had a similar rate of HSRs to the use of ranitidine.
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Antineoplásicos Fitogénicos , Hipersensibilidad a las Drogas , Estudios de Cohortes , Hipersensibilidad a las Drogas/etiología , Hipersensibilidad a las Drogas/prevención & control , Estudio Históricamente Controlado , Humanos , Estudios Multicéntricos como Asunto , Paclitaxel , Premedicación/efectos adversos , Ranitidina/uso terapéutico , Taxoides/efectos adversosRESUMEN
BACKGROUND: Postoperative negative behavioral changes (NBCs) are common among children, but risk for this is thought to be reduced with premedication. Midazolam has for many years been a standard premedication for children. More recently, the alpha-2 adrenergic agonist clonidine has also become popular as a preanesthetic sedative. We hypothesized that clonidine was superior to midazolam for limiting new NBCs in children as assessed using the Post Hospital Behavior Questionnaire (PHBQ). METHODS: This was a prospective, randomized, controlled, blinded study, including 115 participants aged 24 to 95 months and their parents. The participants underwent ear, nose, or throat outpatient surgery and were randomly allocated to premedication with oral midazolam 0.5 mg/kg or oral clonidine 4 µg/kg. Participants were anesthetized by protocol. At home, later, parents were asked to complete the PHBQ assessment instrument for postoperative NBCs for the participants 1 week, 1 month, and 6 months after the surgery. A secondary outcome, preinduction anxiety, was assessed using modified Yale Preoperative Anxiety Scale (mYPAS). RESULTS: The primary outcome, more than 3 NBCs in an individual case at 1 week, showed no difference in proportions between treatment in the clonidine group compared to the midazolam group, (12/59 or 20% vs 7/56 or 13%, respectively, odds ratio 1.39, 95% confidence interval [CI], 0.75-2.58; P = .32). A secondary result showed a higher preinduction anxiety level in the clonidine compared to the midazolam group (mYPAS >30, 43/59 or 71% vs 12/56 or 21%, respectively; P < .001). CONCLUSIONS: These results did not show a clinical or statistically significant difference, with respect to the primary outcome of behavior changes at 1 week, between the cohorts that received midazolam versus clonidine as a premedication.
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Clonidina , Midazolam , Niño , Clonidina/efectos adversos , Método Doble Ciego , Humanos , Midazolam/efectos adversos , Medicación Preanestésica , Premedicación/efectos adversos , Estudios ProspectivosRESUMEN
BACKGROUND: Ranitidine, a histamine 2 blocker, is the standard of care to prevent hypersensitivity reactions (HSRs) caused by paclitaxel infusion. However, the added value of ranitidine in this premedication regimen is controversial. Therefore, we compared the incidence of HSRs during paclitaxel treatment between a standard regimen including ranitidine and a regimen without ranitidine. METHODS: This prospective, pre-post interventional, non-inferiority study compared the standard premedication regimen (N = 183) with dexamethasone, clemastine and ranitidine with a premedication regimen without ranitidine (N = 183). The primary outcome was the incidence of HSR grade ≥3. Non-inferiority was determined by checking whether the upper bound of the two-sided 90% confidence interval (CI) for the difference in HSR rates excluded the +6% non-inferiority margin. RESULTS: In both the pre-intervention (with ranitidine) and post-intervention (without ranitidine) group 183 patients were included. The incidence of HSR grade ≥3 was 4.4% (N = 8) in the pre-intervention group and 1.6% (N = 3) in the post-intervention group: difference -2.7% (90% CI: -6.2 to 0.1). CONCLUSIONS: As the upper boundary of the 90% CI does not exceed the predefined non-inferiority margin of +6%, it can be concluded that a premedication regimen without ranitidine is non-inferior to a premedication regimen with ranitidine. CLINICAL TRIAL REGISTRATION: www.trialregister.nl ; NL8173.
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Hipersensibilidad a las Drogas/prevención & control , Neoplasias/tratamiento farmacológico , Paclitaxel/efectos adversos , Premedicación/métodos , Ranitidina/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Quimioprevención/efectos adversos , Quimioprevención/métodos , Clemastina/administración & dosificación , Dexametasona/administración & dosificación , Hipersensibilidad a las Drogas/epidemiología , Hipersensibilidad a las Drogas/patología , Quimioterapia Combinada , Estudios de Equivalencia como Asunto , Femenino , Antagonistas de los Receptores H2 de la Histamina/administración & dosificación , Antagonistas de los Receptores H2 de la Histamina/uso terapéutico , Humanos , Infusiones Intravenosas , Masculino , Inutilidad Médica , Persona de Mediana Edad , Neoplasias/epidemiología , Neoplasias/patología , Países Bajos/epidemiología , Paclitaxel/administración & dosificación , Premedicación/efectos adversos , Ranitidina/administración & dosificación , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
INTRODUCTION: Oxaliplatin is a third generation anti-neoplastic platinum compound (organo-platinum complex) used in the treatment of several solid tumours either as a single agent or in combination with other chemotherapy drugs. Hypersensitivity reactions to oxaliplatin are uncommon, with most reports indicating an incidence of 1-5%. The severity of reactions may vary from grade 1 side effect in line of skin flushing and/or rashes to very severe, life-threatening systemic anaphylaxis (grade 3/4). Following mild to moderate hypersensitivity reactions, steroids and/or antihistamines could be administered, after which the patient can be re-exposed to the drug. In severe hypersensitivity reactions however, oxaliplatin must be discontinued while alternative chemotherapeutic regimen or even other forms of therapy should be considered. CASE REPORT: A 56 year old woman with colorectal cancer who was commenced on adjuvant oxaliplatin therapy developed Hypersensitivity reaction about 2 hours of the first oxaliplatin administration, for which the drug was discontinued and the symptoms improved. She had similar reactions in 2 subsequent attempts at administering same drug, after which the drug was changed. A placebo infusion was administered twice with no untoward reactions.Management and outcome: With each reaction, the drug was immediately discontinued and she was promptly given intranasal oxygen and corticosteroids. She was premedicated with anti-histamines and corticosteroids prior to subsequent cycles. Oxaliplatin was consequently discontinued and she experienced no further hypersensitivity reaction to the subsequent drug regimen. DISCUSSION: Hypersensitivity reactions to oxaliplatin, though a rare occurrence, are more likely idiosyncratic; with more cases being reported in recent times.
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Neoplasias Colorrectales/tratamiento farmacológico , Hipersensibilidad a las Drogas/etiología , Oxaliplatino/efectos adversos , Antineoplásicos/efectos adversos , Femenino , Humanos , Hipersensibilidad Tardía/inducido químicamente , Persona de Mediana Edad , Nigeria , Oxaliplatino/uso terapéutico , Premedicación/efectos adversosRESUMEN
BACKGROUND: Safety incident reporting is essential in medical imaging (MI) departments due to the fast-paced environment and high patient volume. However, there is an evident knowledge gap in the identification and investigation of contributing factors to incidents reports in MI departments. The objective of this study was to investigate the following rates of incident reporting in a MI department at a large academic health sciences centre: departmental incident rate, incident rates per imaging modality, and incident rates per incident type. Characteristics associated with the most frequently occurring incident types were examined to identify opportunities for quality improvement. METHODS: This observational, retrospective study collected approximately 665 MI incident reports submitted by staff between July 2018 and July 2019. Individual incident reports were categorized according to imaging modality and incident type. Subcategories of the top four incident types were also created to identify possible contributory factors based on the staff member's safety incident report submission. RESULTS: The safety incident rate for the entire medical imaging department was 0.263%. The safety incident reporting rate was calculated (# of incidents reported per modality total/ # of completed exams in that modality x 100%) for each modality and varied from 0.113 to 1.26%. The four highest safety incident rates were from adverse drug reaction (ADR) (21.5%), followed by delay in care/treatment (18.9%), identification/documentation/order (18.5%) and extravasation (11.4%). Possible contributory factors involved transfer of accountability (TOA)/communication barriers, and incorrect ordering information. Further analysis was also completed to assess whether patients that experienced an ADR or extravasation incident followed the correct protocols. DISCUSSION: This study demonstrated the importance of how analysis of incident report data can be used to uncover opportunities for quality improvement in the medical imaging department. However, more information must be collected at the time of safety incident report submission to allow for quality improvement. Investigators hope that by future standardization of safety incident reporting, with the increased use of drop-down menus to capture more open-ended responses, corrective strategies can be implemented to address safety concerns in MI departments. In comparison to incident reporting rates published in similar studies, there may be a significant underrepresentation of safety incident reports filed from underreporting. Reducing barriers to reporting is essential in improving the effectiveness of the current safety incident reporting system.
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Errores Médicos/estadística & datos numéricos , Seguridad del Paciente , Servicio de Radiología en Hospital , Gestión de Riesgos/métodos , Centros Médicos Académicos , Sistemas de Registro de Reacción Adversa a Medicamentos , Medios de Contraste/efectos adversos , Extravasación de Materiales Terapéuticos y Diagnósticos/complicaciones , Investigación sobre Servicios de Salud , Humanos , Premedicación/efectos adversos , Estudios Retrospectivos , Listas de EsperaAsunto(s)
Corticoesteroides/administración & dosificación , Antialérgicos/administración & dosificación , Medios de Contraste/efectos adversos , Hipersensibilidad a las Drogas/prevención & control , Isquemia Miocárdica/terapia , Intervención Coronaria Percutánea , Premedicación , Radiografía Intervencional/efectos adversos , Corticoesteroides/efectos adversos , Anciano , Antialérgicos/efectos adversos , Medios de Contraste/administración & dosificación , Esquema de Medicación , Hipersensibilidad a las Drogas/etiología , Urgencias Médicas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico por imagen , Intervención Coronaria Percutánea/efectos adversos , Premedicación/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the effects of intravenous maropitant on arterial blood pressure in healthy dogs while awake and under general anesthesia. DESIGN: Experimental crossover study. ANIMALS: Eight healthy adult Beagle dogs. PROCEDURE: All dogs received maropitant (1 mg kg-1) intravenously under the following conditions: 1) awake with non-invasive blood pressure monitoring (AwNIBP), 2) awake with invasive blood pressure monitoring (AwIBP), 3) premedication with acepromazine (0.005 mg kg-1) and butorphanol (0.2 mg kg-1) intramuscularly followed by propofol induction and isoflurane anesthesia (GaAB), and 4) premedication with dexmedetomidine (0.005 mg kg-1) and butorphanol (0.2 mg kg-1) intramuscularly followed by propofol induction and isoflurane anesthesia (GaDB). Heart rate (HR), systolic (SAP), diastolic (DAP), and mean blood pressures (MAP) were recorded before injection of maropitant (baseline), during the first 60 seconds of injection, during the second 60 seconds of injection, at the completion of injection and every 2 minutes post injection for 18 minutes. The data were compared over time using a Generalized Linear Model with mixed effects and then with simple effect comparison with Bonferroni adjustments (p <0.05). RESULTS: There were significant decreases from baseline in SAP in the GaAB group (p < 0.01) and in MAP and DAP in the AwIBP and GaAB (p < 0.001) groups during injection. A significant decrease in SAP (p < 0.05), DAP (p < 0.05), and MAP (p < 0.05) occurred at 16 minutes post injection in GaDB group. There was also a significant increase in HR in the AwIBP group (p < 0.01) during injection. Clinically significant hypotension occurred in the GaAB group with a mean MAP at 54 ± 6 mmHg during injection. CONCLUSION: Intravenous maropitant administration significantly decreases arterial blood pressure during inhalant anesthesia. Patients premedicated with acepromazine prior to isoflurane anesthesia may develop clinically significant hypotension.
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Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Presión Sanguínea/efectos de los fármacos , Quinuclidinas/administración & dosificación , Quinuclidinas/efectos adversos , Acepromazina/efectos adversos , Anestesia por Inhalación/veterinaria , Animales , Enfermedades de los Perros/inducido químicamente , Enfermedades de los Perros/fisiopatología , Perros , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Hipotensión/inducido químicamente , Hipotensión/fisiopatología , Hipotensión/veterinaria , Inyecciones Intravenosas/veterinaria , Modelos Lineales , Modelos Animales , Premedicación/efectos adversos , Premedicación/veterinaria , VigiliaRESUMEN
PURPOSE: In order to reduce postoperative opioid administration and pain levels in patients submitted to laparoscopic colectomy, we assessed the efficacy of preemptive use of pregabalin (PG), as part of a multimodal analgesia scheme, in a randomized controlled trial setting. METHODS: Overall, fifty adult patients scheduled for elective laparoscopic colectomy were included and randomized in our trial. In the experimental group, 23 patients received preoperatively 2 doses of 150 mg PG per os, whereas the control group consisted of 27 cases, where a matching to PG placebo was administered at the same scheme. The two groups had identical analgesia and anesthesia regimens otherwise. Our study endpoints included postoperative morphine consumption, postoperative pain, and complication rates. RESULTS: Patients in the PG group displayed a significantly reduced morphine consumption at 8 h, 24 h, and 48 h postoperatively. The two groups were comparable in terms of postoperative pain (rest and movement assessment) and side effects. CONCLUSIONS: The preoperative addition of PG resulted in a significant reduction of the postoperative opioid consumption in patients undergoing laparoscopic colectomy. However, an association with the postoperative pain scores was not identified.
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Analgésicos Opioides/administración & dosificación , Analgésicos/administración & dosificación , Colectomía/efectos adversos , Laparoscopía/efectos adversos , Morfina/administración & dosificación , Manejo del Dolor , Dolor Postoperatorio/prevención & control , Pregabalina/administración & dosificación , Premedicación , Anciano , Analgésicos/efectos adversos , Analgésicos Opioides/efectos adversos , Esquema de Medicación , Femenino , Grecia , Humanos , Masculino , Persona de Mediana Edad , Morfina/efectos adversos , Manejo del Dolor/efectos adversos , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Pregabalina/efectos adversos , Premedicación/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Etoposide is critical in treating pediatric cancers, although hypersensitivity can be severe and treatment-limiting. Reported rates of hypersensitivity range from 2% to 51%. Hypersensitivity data for etoposide phosphate, a newer product, are lacking. The primary objective of this study was to assess etoposide and etoposide phosphate hypersensitivity incidence. Secondary objectives included evaluation of potential risk factors for hypersensitivity and strategies to prevent recurrence. METHODS: This retrospective cohort study evaluated pediatric patients who received initial etoposide phosphate or etoposide dose between August 2012 and July 2017. The primary outcome was documentation of hypersensitivity within four months of initial dose. Potential risk factors evaluated included age, allergies, dose, infusion rate, infusion concentration, and premedication. RESULTS: Of 246 patients, hypersensitivity reactions occurred in five of 54 patients (9.3%) who received etoposide phosphate and 52 of 192 patients (27.1%) who received etoposide (p = 0.0061). For etoposide, the mean initial infusion rate was 64.6 ± 40.9 mg/m2/h for patients with hypersensitivity and 49.5 ± 33.4 mg/m2/h without hypersensitivity (p = 0.0886). Etoposide phosphate rate was not associated with hypersensitivity. Recurrent hypersensitivity occurred in one of nine patients (11.1%) who received etoposide desensitization and one of 38 patients (2.6%) who changed formulation to etoposide phosphate. CONCLUSIONS: Etoposide was associated with more hypersensitivity than etoposide phosphate in pediatric patients. Etoposide hypersensitivity was associated with higher infusion rates, but not etoposide phosphate. Differences in hypersensitivity incidence and infusion rate influence indicate a formulation-effect. Etoposide hypersensitivity recurrence may be prevented by changing to etoposide phosphate formulation. During etoposide phosphate shortages, etoposide desensitization may prevent recurrent hypersensitivity.
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Hipersensibilidad a las Drogas/etiología , Etopósido/análogos & derivados , Neoplasias/tratamiento farmacológico , Compuestos Organofosforados/administración & dosificación , Adolescente , Niño , Preescolar , Desensibilización Inmunológica , Etopósido/administración & dosificación , Etopósido/efectos adversos , Femenino , Humanos , Incidencia , Masculino , Compuestos Organofosforados/efectos adversos , Premedicación/efectos adversos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
INTRODUCTION: Premedication of surgical patients with benzodiazepines has become questionable regarding risk-benefit ratio and lack of evidence. Though preoperative benzodiazepines might alleviate preoperative anxiety, a higher risk for adverse events is described, particularly for elderly patients (≥ 65 years). Several German hospitals already withhold benzodiazepine premedication from elderly patients, though evidence for this approach is lacking. The patient-centred outcome known as global postoperative patient satisfaction is recognised as a substantial quality indicator of anaesthesia care incorporated by the American Society of Anesthesiologists. Therefore, we aim to assess whether the postoperative patient satisfaction after premedication with placebo compared to the preoperative administration of 3.75 mg midazolam in elderly patients differs. METHODS: This study is a multicentre, randomised, placebo-controlled, double-blinded, two-arm parallel, interventional trial, conducted in nine German hospitals. In total 614 patients (≥ 65-80 years of age) undergoing elective surgery with general anaesthesia will be randomised to receive either 3.75 mg midazolam or placebo. The primary outcome (global patient satisfaction) will be assessed with the validated EVAN-G questionnaire on the first postoperative day. Secondary outcomes will be assessed until the first postoperative day and then 30 days after surgery. They comprise among other things: functional and cognitive recovery, postoperative delirium, health-related quality of life assessment, and mortality or new onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury. Analysis will adhere to the intention-to-treat principle. The primary outcome will be analysed with the use of mixed linear models including treatment effect and study centre as factors and random effects for blocks. Exploratory adjusted and subgroup analyses of the primary and secondary outcomes with regard to gender effects, frailty, pre-operative anxiety level, patient demographics, and surgery experience will also be performed. DISCUSSION: This is, to the best of our knowledge, the first study analysing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high-quality data for the decision-making process regarding premedication in elderly surgical patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03052660 . Registered on 14 February 2017. EudraCT 2016-004555-79 .
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Hipnóticos y Sedantes/administración & dosificación , Midazolam/administración & dosificación , Satisfacción del Paciente , Premedicación/métodos , Cuidados Preoperatorios/métodos , Factores de Edad , Anciano , Anciano de 80 o más Años , Toma de Decisiones Clínicas , Método Doble Ciego , Esquema de Medicación , Femenino , Alemania , Humanos , Hipnóticos y Sedantes/efectos adversos , Masculino , Midazolam/efectos adversos , Estudios Multicéntricos como Asunto , Premedicación/efectos adversos , Cuidados Preoperatorios/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Analysing national patients' profile and organisation of human resources are important for improving the perioperative quality of care. The aim of the current study was to achieve these goals using the French data from the APRICOT study. MATERIAL AND METHODS: Data from the French centres that participated to the APRICOT study were extracted and analysed. The primary goal of the study was to describe patients' characteristics, procedures and perioperative anaesthetic management in France, and compare them to the results of the European APRICOT trial. Secondary outcomes were the description of major perioperative complications and the determination of human resources organisation possibly associated with these perioperative complications. RESULTS: Overall 3535 procedures collected in 20 facilities (17 teaching hospitals, one community hospital and two private institutions) were analysed. Comparison between the French and European APRICOT cohorts found differences related to the more specialised French centres participating to the study. Overall complications (respiratory complications, haemodynamic instability, cardiac arrest, drug errors, and anaphylactic reactions) were observed in 6.4% [95% CI: 5.6; 6.3] of cases. Multivariate analysis identified the anaesthesiologist's experience of<15 years and the absence of an anaesthetic nurse as human factors independently associated with an increased risk for perioperative complications. DISCUSSION: The current study identified some important differences between the French and the whole APRICOT cohort in terms of preoperative evaluation, surgical specialties involved, and monitoring of neuromuscular blockade. It confirms that, in France, the presence of an anaesthetic nurse and an experienced anaesthesiologist prevents anaesthetic complications.
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Anestesia/métodos , Estudios Multicéntricos como Asunto/métodos , Atención Perioperativa/métodos , Adolescente , Anestesia/efectos adversos , Anestesia/enfermería , Niño , Preescolar , Bases de Datos Factuales , Europa (Continente) , Femenino , Francia , Humanos , Lactante , Recién Nacido , Complicaciones Intraoperatorias/epidemiología , Masculino , Fármacos Neuromusculares/administración & dosificación , Fármacos Neuromusculares/efectos adversos , Sistemas en Línea , Atención Perioperativa/efectos adversos , Complicaciones Posoperatorias/epidemiología , Premedicación/efectos adversos , Premedicación/métodos , Estudios Prospectivos , Intubación e Inducción de Secuencia Rápida/efectos adversos , Factores de Riesgo , Recursos HumanosRESUMEN
BACKGROUND: Perioperative hypothermia is still very common and associated with numerous adverse effects. The effects of benzodiazepines, administered as premedication, on thermoregulation have been studied with conflicting results. We investigated the hypotheses that premedication with flunitrazepam would lower the preoperative core temperature and that prewarming could attenuate this effect. METHODS: After approval by the local research ethics committee 50 adult cardiac surgical patients were included in this prospective, randomized, controlled, single-centre study with two parallel groups in a university hospital setting. Core temperature was measured using a continuous, non-invasive zero-heat flux thermometer from 30 min before administration of the oral premedication until beginning of surgery. An equal number of patients was randomly allocated via a computer-generated list assigning them to either prewarming or control group using the sealed envelope method for blinding. The intervention itself could not be blinded. In the prewarming group patients received active prewarming using an underbody forced-air warming blanket. The data were analysed using Student's t-test, Mann-Whitney U-test and Fisher's exact test. RESULTS: Of the randomized 25 patients per group 24 patients per group could be analysed. Initial core temperature was 36.7 ± 0.2 °C and dropped significantly after oral premedication to 36.5 ± 0.3 °C when the patients were leaving the ward and to 36.4 ± 0.3 °C before induction of anaesthesia. The patients of the prewarming group had a significantly higher core temperature at the beginning of surgery (35.8 ± 0.4 °C vs. 35.5 ± 0.5 °C, p = 0.027), although core temperature at induction of anaesthesia was comparable. Despite prewarming, core temperature did not reach baseline level prior to premedication (36.7 ± 0.2 °C). CONCLUSIONS: Oral premedication with benzodiazepines on the ward lowered core temperature significantly at arrival in the operating room. This drop in core temperature cannot be offset by a short period of active prewarming. TRIAL REGISTRATION: This trial was prospectively registered with the German registry of clinical trials under the trial number DRKS00005790 on 20th February 2014.
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Benzodiazepinas/efectos adversos , Temperatura Corporal/fisiología , Procedimientos Quirúrgicos Cardíacos/métodos , Calor/uso terapéutico , Premedicación/efectos adversos , Cuidados Preoperatorios/métodos , Administración Oral , Adulto , Anciano , Benzodiazepinas/administración & dosificación , Temperatura Corporal/efectos de los fármacos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Femenino , Humanos , Hipotermia/inducido químicamente , Hipotermia/prevención & control , Masculino , Persona de Mediana Edad , Premedicación/tendencias , Cuidados Preoperatorios/tendencias , Estudios ProspectivosRESUMEN
BACKGROUND: During induction of general anesthesia, proper mask ventilation is crucial for supplying sufficient oxygen to unconscious patients. Midazolam has a relaxing effect on airway muscles. We hypothesized that sedative premedication with midazolam would facilitate mask ventilation during anesthetic induction. METHODS: Patients undergoing elective surgery under general anesthesia were randomized into 2 groups. The midazolam group received midazolam premedication at the reception area, 3 minutes before transfer to the operating room. Patients in the control group were treated with normal saline as a placebo. The primary outcome was difficulty of mask ventilation during induction, as evaluated using the Warters scales. RESULTS: A total of 97 patients completed the analysis: 49 in the control group and 48 in the midazolam group. The patients in the midazolam group showed a significantly lower mask ventilation difficulty score on the Warters scale than that of the control group (mean [standard deviation], 0.92 [1.13] vs 0.19 [0.57]; estimated difference [95% confidence interval], 0.73 [0.37-1.09]; P < .001). The incidence of difficult mask ventilation (≥2 Warters scale) was significantly lower in the midazolam group than in the control group (risk ratio [95% confidence interval], 0.15 [0.03-0.72]; P = .015). CONCLUSIONS: This randomized clinical trial demonstrated that midazolam premedication enhanced mask ventilation during induction of general anesthesia.
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Anestesia General/instrumentación , Midazolam/administración & dosificación , Fármacos Neuromusculares/administración & dosificación , Premedicación , Respiración Artificial/instrumentación , Adulto , Anestesia General/efectos adversos , Esquema de Medicación , Diseño de Equipo , Femenino , Humanos , Masculino , Midazolam/efectos adversos , Persona de Mediana Edad , Fármacos Neuromusculares/efectos adversos , Premedicación/efectos adversos , Respiración Artificial/efectos adversos , Seúl , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: While it is suggested that platelet hyperreactivity plays a role in the arterial thrombi, its link with venous thromboembolism (VTE) is not well defined. Aggregometry using low concentrations of agonists is proposed as a reliable method to detect hyperreactivity. The aim of this study was to examine whether platelet hyperreactivity affects the development of VTE after total knee arthroplasty (TKA). METHODS: Total 150 elderly patients without VTE history were enrolled. Mechanical prophylaxis was used for VTE after TKA. We performed platelet aggregation using Chrono-log (Chrono-log Corporation, USA) in the presence of low concentrations of ADP (1.0 µmol/L) and epinephrine (0.4, 1.0 µmol/L), and measured maximal aggregation (%). RESULTS: At 0.4 µmol/L epinephrine, 69.3%, 15.3%, and 15.3% displayed low (<40%), moderate (40-60%), and high (>60%) levels of aggregation, respectively. The proportion of high level of aggregation was 36.7%, 30.7% at 1.0 µmol/L of epinephrine and ADP, respectively. The incidence of VTE was higher in the moderate/high aggregation group (10/46, 21.7%) than in the low aggregation group (1/104, 1.0%) at 0.4 µmol/L epinephrine (P < 0.0001). In predicting postoperative VTE, sensitivity and specificity of ≥40% aggregation at 0.4 µmol/L epinephrine were 90.9% and 74.1%. Higher mean platelet volume and lower volume of blood loss were seen in the high aggregation group than in the low aggregation group. CONCLUSION: Aggregation response to 0.4 µmol/L epinephrine is an optimal assay to classify platelet activity. Platelet hyperreactivity may increase the risk of postoperative VTE in an elderly population, and can be an indication of pharmacologic prophylaxis.
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Artroplastia de Reemplazo de Rodilla/efectos adversos , Activación Plaquetaria/efectos de los fármacos , Premedicación/efectos adversos , Tromboembolia Venosa/etiología , Anciano , Epinefrina/farmacología , Femenino , Humanos , Masculino , Volúmen Plaquetario Medio , Persona de Mediana EdadRESUMEN
OBJECTIVE: To characterize the impact of premedication with and without a paralytic agent on the safety of tracheal intubation (TI) in infants ≤1500 g. STUDY DESIGN: A prospective observational cohort study between February 2015 and June 2017. The primary outcomes were associations between the use of different premedication regimens with number of TI attempts, TI adverse events (TIAEs), and changes in heart rate. RESULTS: Data were collected on 237 TIs. Median postmenstrual age at intubation was 28 completed weeks and weight was 953 g. Premedication with a paralytic was associated with fewer intubation attempts compared to premedication without a paralytic (p = 0.037). Premedication with a paralytic was associated with fewer TIAEs (p < 0.001) and less bradycardia compared to the other two regimens (p = 0.003) compared to premedication without a paralytic. CONCLUSIONS: Premedication with a paralytic was associated with fewer intubation attempts, fewer TIAEs, and less bradycardia. Premedication with a paralytic may improve intubation safety in VLBWs.