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1.
Trials ; 22(1): 627, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526095

RESUMO

BACKGROUND: Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. METHODS/DESIGN: The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24-72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. TRIAL REGISTRATION: ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.


Assuntos
Permeabilidade do Canal Arterial , Pré-Escolar , Permeabilidade do Canal Arterial/diagnóstico por imagem , Permeabilidade do Canal Arterial/terapia , Humanos , Ibuprofeno/efeitos adversos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Conduta Expectante
2.
Expert Rev Respir Med ; 15(8): 979-983, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34196258

RESUMO

Introduction: The Coronavirus disease 2019 (COVID-19) poses novel challenges in the healthcare systems around the world. Concern about the role of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and, in particular, ibuprofen has led to significant speculation.Areas covered: A literature search was conducted to evaluate ibuprofen's potential benefits and harms in the COVID-19 disease. Angiotensin-Converting Enzyme 2 (ACE-2) is crucial entry receptor for Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) in host cells. We found no scientific evidence linking ibuprofen use and an ACE-2 overexpression. Ibuprofen suppresses the production of various pro-inflammatory cytokines that are implicated in the 'cytokine storm' and subsequent ARDS in COVID-19 disease. Nevertheless, the exact role of ibuprofen in the immune response in COVID-19 disease is still unknown. There are no double-blind, placebo-controlled studies assessing the effect of ibuprofen on COVID-19 disease progression.Expert opinion: The studies that have been performed so far demonstrate no association between ibuprofen use and increased mortality rates or an increased risk for respiratory support. Accordingly, we recommend ibuprofen to be used for managing COVID-19 symptoms.


Assuntos
COVID-19 , Ibuprofeno , Anti-Inflamatórios não Esteroides/efeitos adversos , Citocinas , Humanos , Ibuprofeno/efeitos adversos , SARS-CoV-2
3.
Biomed Pharmacother ; 139: 111710, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34243616

RESUMO

PURPOSE: Postoperative pain is typically treated with multimodal analgesia, using systemic acetaminophen and/or nonsteroidal anti-inflammatory drugs in conjunction with opioids as required. The present study aimed to determine the safety and tolerability of repeated doses of an intravenous fixed-dose combination (FDC) of acetaminophen and ibuprofen. METHODS: This multicenter, open-label, single arm, multiple dose study was conducted at 4 centers across New Zealand and the United States between July 2019 and July 2020. Adults (>18 years) requiring multiple doses of parenteral nonopioid analgesics over multiple days following non-laparoscopic general, plastic or orthopedic surgery were eligible. The study drug (acetaminophen 1000 mg+ibuprofen 300 mg) was administered 6-hourly as a 5 min infusion for between 48 h and 5 days. Adverse event data was collected throughout the study, in addition to scheduled vital sign assessments, laboratory tests and electrocardiograms. Participants completed a global evaluation of the FDC at the end of the treatment period. FINDINGS: 232 participants received ≥ 1 dose of the FDC. Most were female (62.1%), White (56.5%) or Black or African American (39.2%), and had undergone orthopedic surgery (85.3%). There was a broad age range (19-87 years), with a mean age of 53.4 years, and 26.3% of participants aged ≥ 65 years. The FDC was safe when used for 48 h to 5 days. Treatment-emergent adverse events (TEAEs) affected 56.0% of participants, the most common were infusion site pain, nausea, infusion site extravasation, constipation, and headache. Minimal changes in vital signs were observed at scheduled timepoints. No clinically significant changes in electrocardiogram assessments occurred. Transient elevations in the hepatic enzymes ALT and AST to < 3 times the upper limit of normal (ULN) affected 10.5% and 9.6% of subjects, elevations to ≥ 3 times the ULN affected 2.6% and 2.2% of subjects, respectively. There were no apparent differences in the safety profile of the FDC in older participants. The FDC was well tolerated; most TEAEs were mild or moderate in severity. Five participants discontinued treatment due to TEAEs, none were considered treatment-related. The FDC was perceived well by study participants; the majority rated their experience as 'excellent' (40.1%) or 'very good' (35.3%). IMPLICATIONS: The safety profile was comparable to previous studies with no novel safety concerns. The FDC was safe, well tolerated, and perceived positively by participants treated for acute pain between 48 h and 5 days following orthopedic or plastic surgery, supporting a favorable risk benefit profile.


Assuntos
Acetaminofen/administração & dosagem , Acetaminofen/efeitos adversos , Ibuprofeno/administração & dosagem , Ibuprofeno/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Dor Aguda/tratamento farmacológico , Administração Intravenosa/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos não Narcóticos/administração & dosagem , Analgésicos não Narcóticos/efeitos adversos , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Medição da Dor/métodos , Adulto Jovem
4.
Trials ; 22(1): 368, 2021 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-34039414

RESUMO

BACKGROUND: The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analysis plan for the short-term health outcomes of the Baby-OSCAR trial. METHODS AND DESIGN: This is a randomised controlled trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies improves short and long-term health and economic outcomes. Infants born between 23+0 and 28+6 weeks of gestation, confirmed by echocardiography as having a large PDA (with a diameter of at least 1.5 mm and unrestricted pulsatile PDA flow pattern), with parental informed consent, were randomly allocated to receive either ibuprofen or placebo within 72 h of birth. The primary outcome is a composite of death by 36 weeks' postmenstrual age or moderate or severe bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age. RESULTS: Baseline demographic and clinical characteristics will be described by randomised group. The primary analysis will be on the modified intention to treat (ITT) population. Counts and percentages will be presented for binary and categorical variables, and mean and standard deviation or median and interquartile range will be presented for continuous variables. For binary outcomes, risk ratios and confidence intervals will be calculated using log binomial or Poisson regression with a robust variance estimator. Continuous outcomes will be analysed using linear regression models, or quantile regression models if skewed. Analyses will be adjusted for all minimisation factors where technically possible, and correlation between siblings from multiple births will be accounted for by nesting the clusters as a random effect. Both crude and adjusted effect estimates will be presented, with the primary inference based on the adjusted estimates. Ninety-five per cent confidence intervals will be used for all pre-specified outcome comparisons. CONCLUSION: This paper describes the statistical analysis plan for short-term health outcomes of the trial, including the analysis principles, definitions of important outcomes, methods for primary analysis, pre-specified subgroup analysis, and secondary analysis. The plan was finalised prior to completion of short-term follow-up. TRIAL REGISTRATION: ISRCTN registry ISRCTN84264977 . Registered on 15 September 2010.


Assuntos
Displasia Broncopulmonar , Permeabilidade do Canal Arterial , Displasia Broncopulmonar/diagnóstico , Permeabilidade do Canal Arterial/diagnóstico por imagem , Permeabilidade do Canal Arterial/tratamento farmacológico , Humanos , Ibuprofeno/efeitos adversos , Lactente , Lactente Extremamente Prematuro , Recém-Nascido de Baixo Peso , Recém-Nascido , Resultado do Tratamento
5.
Paediatr Drugs ; 23(4): 361-372, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34046854

RESUMO

Nonsteroidal anti-inflammatory drugs (NSAIDs) are often used for pediatric pain management in the emergency setting and postoperatively. This narrative literature review evaluates pain relief, opioid requirements, and adverse effects associated with NSAID use. A PubMed search was conducted to identify randomized controlled trials evaluating the use of conventional systemic NSAIDs as pain management for children in the perioperative or emergency department (traumatic injury) setting. Trials of cyclooxygenase-2 inhibitors ("coxibs") were excluded. Search results included studies of ibuprofen (n = 12), ketoprofen (n = 5), ketorolac (n = 6), and diclofenac (n = 4). NSAIDs reduced the opioid requirement in 10 of 13 studies in which this outcome was measured. NSAID use did not compromise pain relief; NSAIDs provided improved or similar pain scores compared with opioids (or other control) in 24 of 27 studies. Adverse event frequencies were reported in 26 studies; adverse event frequencies with NSAIDs were lower than with opioids (or other control) in three of 26 studies, similar in 21 of 26 studies, and more frequent in two of 26 studies. Perioperative and emergency department use of NSAIDs may reduce opioid requirements while maintaining pain control, with similar or reduced frequencies of opioid-associated adverse events.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Serviço Hospitalar de Emergência , Manejo da Dor/métodos , Dor/tratamento farmacológico , Assistência Perioperatória/métodos , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Ibuprofeno/administração & dosagem , Ibuprofeno/efeitos adversos , Dor/diagnóstico , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/tratamento farmacológico
6.
Med J Aust ; 214(8): 370-375, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33846971

RESUMO

OBJECTIVE: To assess the analgesic efficacy and safety of single-dose oral cannabidiol (CBD) as an adjunct to standard care for patients presenting to an emergency department with acute low back pain. DESIGN: Randomised, double blinded, placebo-controlled clinical trial. SETTING: The tertiary emergency department of Austin Hospital, Melbourne. PARTICIPANTS: Patients who presented with acute, non-traumatic low back pain between 21 May 2018 and 13 June 2019. INTERVENTION: One hundred eligible patients were randomised to receiving 400 mg CBD or placebo in addition to standard emergency department analgesic medication. MAIN OUTCOME MEASURES: Pain score two hours after administration of study agent, on a verbal numerical pain scale (range, 0-10). Secondary outcomes were length of stay, need for rescue analgesia, and adverse events. RESULTS: The median age of the 100 participants was 47 years (IQR, 34-60 years); 44 were women. Mean pain scores at two hours were similar for the CBD (6.2 points; 95% CI, 5.5-6.9 points) and placebo groups (5.8 points; 95% CI, 5.1-6.6 points; absolute difference, -0.3 points; 95% CI, -1.3 to 0.6 points). The median length of stay was 9.0 hours (IQR, 7.4-12 hours) for the CBD group and 8.5 hours (IQR, 6.5-21 hours) for the placebo group. Oxycodone use during the four hours preceding and the four hours after receiving CBD or placebo was similar for the two groups, as were reported side effects. CONCLUSION: CBD was not superior to placebo as an adjunct medication for relieving acute non-traumatic low back pain in the emergency department. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618000487213 (prospective).


Assuntos
Dor Aguda/terapia , Canabidiol/administração & dosagem , Dor Lombar/terapia , Acetaminofen/administração & dosagem , Acetaminofen/efeitos adversos , Dor Aguda/diagnóstico , Administração Oral , Adulto , Austrália , Canabidiol/efeitos adversos , Método Duplo-Cego , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Ibuprofeno/administração & dosagem , Ibuprofeno/efeitos adversos , Tempo de Internação/estatística & dados numéricos , Dor Lombar/diagnóstico , Masculino , Pessoa de Meia-Idade , Medição da Dor/estatística & dados numéricos , Placebos/administração & dosagem , Placebos/efeitos adversos , Centros de Atenção Terciária/estatística & dados numéricos , Resultado do Tratamento
7.
JAMA Netw Open ; 4(3): e210775, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33662136

RESUMO

Importance: Ibuprofen is widely used in children worldwide, especially in those with cancer, fever, or trauma. However, large and high-quality studies of the association between ibuprofen and acute kidney injury (AKI) in children have been lacking. Objective: To examine the association between the use of ibuprofen and the risk of hospital-acquired AKI in hospitalized children in China. Design, Setting, and Participants: This cohort study analyzed the cohort of the Epidemiology of AKI in Chinese Hospitalized Patients (EACH) study, a large, multicenter retrospective study of 3 044 023 patients who were admitted to 1 of 25 academic medical centers in China between January 1, 2013, and December 31, 2015. Patient-level data were obtained from the electronic health record system of the participating centers. Hospitalized children aged 1 month to 18 years who had prescriptions and a certain number of serum creatinine (SCr) tests were included. Children with end-stage renal disease, community-acquired AKI, low baseline SCr level (<10 µmol/L), high standardized baseline SCr level (>4 times the sex- and age-specific reference value), or missing diagnosis code were excluded. Data analysis was conducted from January 1, 2020, to August 30, 2020. Exposures: Exposure to ibuprofen was coded as a time-dependent dichotomous variable. Main Outcomes and Measures: Baseline SCr level was calculated for each patient as the mean of all available SCr values between the 30 days prior to admission and the first SCr testing within the first 3 days of hospitalization. Acute kidney injury was defined as an increase in SCr level of 26.5 µmol/L or higher within 48 hours or by 50% or more over the baseline value, according to the Kidney Disease: Improving Global Outcomes guidelines. Results: Among the 50 420 children (mean [SD] age, 5.0 [5.2] years; 30 640 boys [60.8%]) included in this study, 5526 (11.0%) used ibuprofen and 3476 (6.9%) developed hospital-acquired AKI during hospitalization. Ibuprofen use was associated with a statistically significantly increased risk of hospital-acquired AKI (hazard ratio [HR], 1.23; 95% CI, 1.14-1.34) after adjusting for confounders. Ibuprofen use was associated with a greater hazard in children who had chronic kidney disease vs those without (HR, 2.31 [95% CI, 1.73-3.10] vs 1.19 [95% CI, 1.09-1.29]), required intensive care vs those without this need (HR, 1.47 [95% CI, 1.24-1.75] vs 1.18 [95% CI, 1.07-1.29]), or were older vs younger (>10 years and >1 year to 10 years vs 1 month to 1 year) (HR, 1.64 [95% CI, 1.32-2.05]; 1.36 [95% CI, 1.23-1.52] vs 0.99 [95% CI, 0.86-1.13]). Dose-response analysis suggested that the association of ibuprofen with the risk of hospital-acquired AKI was dose-dependent. Conclusions and Relevance: This study found that ibuprofen was widely used and associated with an increased risk of hospital-acquired AKI in hospitalized children in China. The judicious use of ibuprofen and close monitoring of kidney function in children are needed.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Ibuprofeno/efeitos adversos , Injúria Renal Aguda/epidemiologia , Adolescente , Criança , Pré-Escolar , China , Estudos de Coortes , Feminino , Hospitalização , Humanos , Lactente , Masculino , Medição de Risco
9.
J Am Coll Surg ; 232(5): 765-790.e1, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33515678

RESUMO

BACKGROUND: It is increasingly recognized that non-opioid analgesia is an important analgesia in the perioperative period. Specifically, NSAIDs (nonsteroidal anti-inflammatory drugs) have been touted as an adjunct, or even replacement, for opioids. However, uptake of NSAIDs has been slow due to concern for side effects, including bleeding. We sought to understand the risk of bleeding caused by NSAIDs in the perioperative period. STUDY DESIGN: A physician-librarian team performed a search of electronic databases (MEDLINE, EMBASE), using search terms covering the targeted intervention (use of NSAIDs) and outcomes of interest (surgical complications, bleeding), limited to English language articles of any date. We performed a systematic review and meta-analysis of the data. RESULTS: A total of 2,521 articles were screened, and 229 were selected on the basis of title and abstract for detailed assessment. Including reference searching, 74 manuscripts met inclusion criteria spanning years 1987-2019. These studies included 151,031 patients. Studies included 12 types of NSAIDs, the most common being ketorolac, diclofenac, and ibuprofen, over a wide-range of procedures, from otorhinolaryngology (ENT), breast, abdomen, plastics, and more. More than half were randomized control trials. The meta-analyses for hematoma, return to the operating room for bleeding, and blood transfusions showed no difference in risk in any of 3 categories studied between the NSAID vs non-NSAID groups (p = 0.49, p = 0.79, and p = 0.49, respectively). Quality scoring found a wide range of quality, with scores ranging from lowest quality of 12 to highest quality of 25, out of a total of 27 (average = 16). CONCLUSIONS: NSAIDs are unlikely to be the cause of postoperative bleeding complications. This literature covers a large number of patients and remains consistent across types of NSAIDs and operations.


Assuntos
Analgesia/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Hemorragia Pós-Operatória/epidemiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Analgesia/métodos , Transfusão de Sangue/estatística & dados numéricos , Diclofenaco/efeitos adversos , Humanos , Ibuprofeno/efeitos adversos , Cetorolaco/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Dor Processual/etiologia , Dor Processual/prevenção & controle , Período Perioperatório/estatística & dados numéricos , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/terapia , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Resultado do Tratamento
10.
Int J Pediatr Otorhinolaryngol ; 142: 110627, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33477013

RESUMO

INTRODUCTION: Pediatric tonsillectomy is one of the most common surgical procedures performed in the United States. The safety of ibuprofen use after surgery is debated given concern for increased bleeding. The primary objective of this study was to compare the rate of post-tonsillectomy hemorrhage requiring operative management in patients who received ibuprofen perioperatively vs. patients who did not. METHODS: Retrospective cohort study of patients 0-18 years old who underwent tonsillectomy with or without adenoidectomy (T&A) with recorded inpatient medication administration data at a single tertiary care institution from 1/2005-1/2019. The association between perioperative medication administration and return to operating room (OR) for control was evaluated using multivariable logistic regression adjusted for patient demographics and operative indication. Secondary outcomes evaluated included the time to operative bleed when it occurred. RESULTS: A total of 4098 patients with a median age of 6 years old (IQR 4-10) underwent T&A over the study period. The overall rate of post-tonsillectomy hemorrhage requiring OR was 3.37% (n = 138/4098). After adjustment for confounders, the odds of bleeding requiring OR did not differ significantly between the ibuprofen (OR 1.16, 95% CI (0.76, 1.74), 3.55%, n = 41/1,156, p = 0.47) and non-ibuprofen groups (3.30%, n = 97/2942). The median time to bleeding requiring OR was postoperative day 6.5 (IQR6-8) in the ibuprofen group and day 6 (IQR 3-8) in the non-ibuprofen group. CONCLUSIONS: No difference in post-tonsillectomy hemorrhage requiring OR was observed between patients receiving perioperative ibuprofen versus those patients not receiving this medication. Additional research is required to definitively determine a safe dose and interval for ibuprofen administration following tonsillectomy.


Assuntos
Ibuprofeno , Tonsilectomia , Adenoidectomia , Adolescente , Criança , Pré-Escolar , Humanos , Ibuprofeno/efeitos adversos , Lactente , Recém-Nascido , Dor Pós-Operatória , Hemorragia Pós-Operatória/induzido quimicamente , Hemorragia Pós-Operatória/epidemiologia , Estudos Retrospectivos , Tonsilectomia/efeitos adversos
11.
Ital J Pediatr ; 47(1): 20, 2021 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-33514404

RESUMO

PURPOSE OF REVIEW: Despite its recognized efficacy and tolerability profile, during the last decade a rise of adverse events following ibuprofen administration in children has been reported, including a possible role in worsening the clinical course of infections. Our aim was to critically evaluate the safety of ibuprofen during the course of pediatric infectious disease in order to promote its appropriate use in children. RECENT FINDINGS: Ibuprofen is associated with severe necrotizing soft tissue infections (NSTI) during chickenpox course. Pre-hospital use of ibuprofen seems to increase the risk of complicated pneumonia in children. Conflicting data have been published in septic children, while ibuprofen in the setting of Cystic Fibrosis (CF) exacerbations is safe and efficacious. No data is yet available for ibuprofen use during COVID-19 course. Ibuprofen should not be recommended for chickenpox management. Due to possible higher risks of complicated pneumonia, we suggest caution on its use in children with respiratory symptoms. While it remains unclear whether ibuprofen may have harmful effects during systemic bacterial infection, its administration is recommended in CF course. Despite the lack of data, it is seems cautious to prefer the use of paracetamol during COVID-19 acute respiratory distress syndrome in children.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , COVID-19/tratamento farmacológico , Doenças Transmissíveis/tratamento farmacológico , Ibuprofeno/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , COVID-19/epidemiologia , Criança , Humanos , Ibuprofeno/efeitos adversos , Pandemias , SARS-CoV-2
12.
Clin Ther ; 43(2): 336-348.e7, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33431169

RESUMO

PURPOSE: Use of ibuprofen for the patent ductus arteriosus (PDA) has become increasingly common. This study aimed to evaluate the clinical and economic impact of oral ibuprofen versus intravenous ibuprofen for PDA among preterm infants. METHODS: This retrospective, cohort-based pilot study examined the clinical and economic associations of oral versus intravenous ibuprofen for PDA. A decision-analytic model was constructed, from the hospital perspective, to follow the oral versus intravenous administrations of ibuprofen for PDA and their clinical and economic consequences. The course regimen of either formulation was an initial 10 mg/kg followed by 5 mg/kg at 24- and 48-h intervals. Clinical and resource utilization data were extracted from Cerner medical database, from 2014 through 2018, at the tertiary neonatal intensive care unit setting in Qatar. The primary outcome measures were the rate of successful closure based on the ductal diameter measure after the first course of treatment and the overall direct medical cost of PDA management. A population of 118 neonates was required for results with 80% power and 0.05 significance. Sensitivity analyses involving unit costs and a subgroup analysis based on gestational age and birth weight, added to a second-order probabilistic analysis of all model inputs, were performed. FINDINGS: Forty infants were available for inclusion in the oral ibuprofen study group, not achieving the desired sample size, with successful PDA closure reported in 64% of cases compared with a reduced success of 36% with intravenous ibuprofen (n = 59) (risk ratio = 0.56; 95% CI, 0.32-0.97; P = 0.04), which was associated with economic advantage to oral ibuprofen. The probabilistic analysis illustrated that oral ibuprofen costs less than intravenous ibuprofen in 72% of patient cases, with QAR 48,751 (US $13,356) (95% CI, QAR 47,500-50,000, US $13,014-$13,699) in mean savings. Sensitivity analyses confirmed the robustness of study conclusions and found that the rate of closure success versus failure was the most influential on results, followed by the occurrence of adverse drug events with both intravenous and oral ibuprofen. Although both ibuprofen formulations had similar safety profiles (P = 0.16), the intravenous formulation was associated with a larger number of adverse drug effects. IMPLICATIONS: This is the first cost-effectiveness evaluation of oral versus intravenous formulations of ibuprofen among infants with PDA. The oral ibuprofen might be associated with an enhanced ductal closure at a considerably lower cost. The study results support recent trends in neonatal intensive care unit practices in favor of the oral administration of ibuprofen.


Assuntos
Administração Oral , Análise Custo-Benefício , Inibidores de Ciclo-Oxigenase/economia , Permeabilidade do Canal Arterial/tratamento farmacológico , Ibuprofeno/economia , Recém-Nascido Prematuro , Infusões Intravenosas/economia , Estudos de Coortes , Inibidores de Ciclo-Oxigenase/administração & dosagem , Árvores de Decisões , Feminino , Humanos , Ibuprofeno/administração & dosagem , Ibuprofeno/efeitos adversos , Recém-Nascido de Baixo Peso , Recém-Nascido , Infusões Intravenosas/efeitos adversos , Terapia Intensiva Neonatal , Masculino , Razão de Chances , Projetos Piloto , Estudos Retrospectivos
13.
J Matern Fetal Neonatal Med ; 34(15): 2411-2417, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31510826

RESUMO

AIM: Patent ductus arteriosus (PDA) is treated with ibuprofen and it is known that the clearance of ibuprofen increases with postnatal age. We aimed to study whether postnatal age-adjusted ibuprofen dosages improve the effectiveness of treatment compared to standard ibuprofen dosages after the first days of life. METHODS: A historical cohort of 207 preterm neonates treated with standard ibuprofen dosages (Group A; 2011-2015) was compared to a prospective cohort of 66 preterm neonates treated with postnatal age-adjusted ibuprofen dosages (Group B; 2015-2016). RESULTS: Both groups had comparable background characteristics. Treatment was started after median 6 (25-75th percentile: 4-11) and 5 (25-75th percentile: 4-11) days and effectiveness was 33.2 and 44.7% (p = .17) in groups A and B, respectively. No hemodynamically significant PDA was found in 23/49 (46.9%) of the patients born before 28 weeks after adjusted ibuprofen dosages compared to 48/162 (29.6%) after standard ibuprofen dosages (p = .04). There were significantly more reversible side effects with the postnatal age-adjusted ibuprofen dosages (p = .04). CONCLUSIONS: There seems to be a trend to higher effectiveness with the adjusted ibuprofen dosages in preterm neonates before 28 weeks, but it is associated with more reversible side effects.


Assuntos
Permeabilidade do Canal Arterial , Ibuprofeno , Estudos de Coortes , Permeabilidade do Canal Arterial/tratamento farmacológico , Humanos , Ibuprofeno/efeitos adversos , Recém-Nascido , Recém-Nascido Prematuro , Estudos Prospectivos
14.
Expert Rev Clin Pharmacol ; 14(1): 33-45, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33306914

RESUMO

INTRODUCTION: Ibuprofen is a drug widely used in children who underwent elective tonsillectomy or adenotonsillectomy because compared to the other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) it is considered a safe drug with a low risk of postoperative bleeding. AREAS COVERED: We conducted a systematic review with meta-analysis of randomized clinical trials (RCTs) comparing ibuprofen vs. placebo or not-NSAIDs drugs in children aged up to 17 years of age, who underwent elective tonsillectomy or adenotonsillectomy. We searched in MEDLINE, EMBASE and Cochrane from 1990 through 30 April 2019. We searched www.clinicaltrials.gov for relevant ongoing studies. Our primary outcome was postoperative bleeding requiring surgical intervention. Secondary outcomes were postoperative bleeding not requiring further surgical intervention, the need for blood transfusion, nausea, vomiting, prolonged hospital stay, postoperative pain, and adverse events related to ibuprofen administration. The database search yielded 1227 patients from 7 studies. EXPERT OPINION: Given the imprecision of our estimates, the quality of evidence very low/moderate and the few RCTs identified, the results of this analysis were consistent with either a benefit or a detrimental effect of the administration of ibuprofen and do not provide a definitive answer to the review question. Further studies are needed on this important topic.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Ibuprofeno/administração & dosagem , Hemorragia Pós-Operatória/epidemiologia , Adenoidectomia/métodos , Anti-Inflamatórios não Esteroides/efeitos adversos , Criança , Humanos , Ibuprofeno/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tonsilectomia/métodos
15.
Cochrane Database Syst Rev ; 12: CD013278, 2020 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-33301630

RESUMO

BACKGROUND: Patent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent or treat a PDA. There are concerns regarding adverse effects of NSAIDs in preterm infants. Controversy exists on whether early targeted treatment of a hemodynamically significant (hs) PDA improves clinical outcomes. OBJECTIVES: To assess the effectiveness and safety of early treatment strategies versus expectant management for an hs-PDA in reducing mortality and morbidity in preterm infants. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 6) in the Cochrane Library; MEDLINE via PubMed (1966 to 31 May 2019), Embase (1980 to 31 May 2019), and CINAHL (1982 to 31 May 2019). An updated search was run on 2 October 2020 in the following databases: CENTRAL via CRS Web and MEDLINE via Ovid. We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials (RCT) and quasi-randomized trials. SELECTION CRITERIA: We included RCTs in which early pharmacological treatment, defined as treatment initiated within the first seven days after birth, was compared to no intervention, placebo or other non-pharmacological expectant management strategies for treatment of an hs-PDA in preterm (< 37 weeks' postmenstrual age) or low birth weight (< 2500 grams) infants. DATA COLLECTION AND ANALYSIS: We performed data collection and analyses in accordance with the methods of Cochrane Neonatal. Our primary outcome was all-cause mortality during hospital stay. We used the GRADE approach to assess the certainty of evidence for selected clinical outcomes. MAIN RESULTS: We included 14 RCTs that enrolled 910 infants. Seven RCTs compared early treatment (defined as treatment initiated by seven days of age) versus expectant management and seven RCTs compared very early treatment (defined as treatment initiated by 72 hours of age) versus expectant management. No difference was demonstrated between early treatment versus expectant management (no treatment initiated within the first seven days after birth) for an hs-PDA for the primary outcome of 'all-cause mortality' (6 studies; 500 infants; typical RR 0.80, 95% CI 0.46 to 1.39; typical RD -0.02; 95% CI -0.07 to 0.03; moderate-certainty evidence), or other important outcomes such as surgical PDA ligation (4 studies; 432 infants; typical RR 1.08, 95% CI 0.65 to 1.80; typical RD -0.03; 95% CI -0.09 to 0.03; very low-certainty evidence), chronic lung disease (CLD) (4 studies; 339 infants; typical RR 0.90, 95% CI 0.62 to 1.29; typical RD -0.03; 95% CI -0.10 to 0.03; moderate-certainty evidence), severe intraventricular hemorrhage (IVH) (2 studies; 171 infants; typical RR 0.83,95% CI 0.32 to 2.16; typical RD -0.01; 95% CI -0.08 to 0.06; low-certainty evidence), and necrotizing enterocolitis (NEC) (5 studies; 473 infants; typical RR 2.34,95% CI 0.86 to 6.41; typical RD 0.04; 95% CI 0.01 to 0.08; low-certainty evidence). Infants receiving early treatment in the first seven days after birth were more likely to receive any PDA pharmacotherapy compared to expectant management (2 studies; 232 infants; typical RR 2.30, 95% CI 1.86 to 2.83; typical RD 0.57; 95% CI 0.48 to 0.66; low-certainty evidence). No difference was demonstrated between very early treatment versus expectant management (no treatment initiated within the first 72 hours after birth) for an hs-PDA for the primary outcome of 'all-cause mortality' (7 studies; 384 infants; typical RR 0.94, 95% CI 0.58 to 1.53; typical RD -0.03; 95% CI -0.09 to 0.04; moderate-certainty evidence) or other important outcomes such as surgical PDA ligation (5 studies; 293 infants; typical RR 0.88, 95% CI 0.36 to 2.17; typical RD -0.01; 95% CI -0.05 to 0.02; moderate-certainty evidence), CLD (7 studies; 384 infants; typical RR 0.83, 95% CI 0.63 to 1.08; typical RD -0.05; 95% CI -0.13 to 0.04; low-certainty evidence), severe IVH (4 studies, 240 infants; typical RR 0.64, 95% CI 0.21 to 1.93; typical RD -0.02; 95% CI -0.07 to 0.04; moderate-certainty evidence), NEC (5 studies; 332 infants; typical RR 1.08, 95% CI 0.53 to 2.21; typical RD 0.01; 95% CI -0.04 to 0.06; moderate-certainty evidence) and neurodevelopmental impairment (1 study; 79 infants; RR 0.27, 95% CI 0.03 to 2.31 for moderate/severe cognitive delay at 18 to 24 months; RR 0.54, 95% CI 0.05 to 5.71 for moderate/severe motor delay at 18 to 24 months; RR 0.54, 95% CI 0.10 to 2.78 for moderate/severe language delay at 18 to 24 months; low-certainty evidence). Infants receiving very early treatment in the first 72 hours after birth were more likely to receive any PDA pharmacotherapy compared to expectant management (4 studies; 156 infants; typical RR 1.64, 95% CI 1.31 to 2.05; typical RD 0.69; 95% CI 0.60 to 0.79; very low-certainty evidence). Very early treatment, however, shortened the duration of hospitalization compared to expectant management (4 studies; 260 infants; MD -5.35 days; 95% CI -9.23 to -1.47; low-certainty evidence). AUTHORS' CONCLUSIONS: Early or very early pharmacotherapeutic treatment of an hs-PDA probably does not reduce mortality in preterm infants (moderate-certainty evidence). Early pharmacotherapeutic treatment of hs-PDA may increase NSAID exposure (low-certainty evidence) without likely reducing CLD (moderate-certainty evidence), severe IVH or NEC (low-certainty evidence). We are uncertain whether very early pharmacotherapeutic treatment of hs-PDA also increases NSAID exposure (very low-certainty evidence). Very early treatment probably does not reduce surgical PDA ligation, severe IVH or NEC (moderate-certainty evidence), and may not reduce CLD or neurodevelopmental impairment (low-certainty evidence). Additional large trials that specifically include preterm infants at the highest risk of PDA-attributable morbidity, are adequately powered for patient-important outcomes and are minimally contaminated by open-label treatment are required to explore if early targeted treatment of hs-PDA improves clinical outcomes. There are currently two trials awaiting classification and two ongoing trials exploring this question.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Permeabilidade do Canal Arterial/terapia , Conduta Expectante , Anti-Inflamatórios não Esteroides/efeitos adversos , Causas de Morte , Hemorragia Cerebral Intraventricular/epidemiologia , Doença Crônica , Permeabilidade do Canal Arterial/mortalidade , Enterocolite Necrosante/epidemiologia , Hemodinâmica , Humanos , Ibuprofeno/efeitos adversos , Ibuprofeno/uso terapêutico , Indometacina/efeitos adversos , Indometacina/uso terapêutico , Recém-Nascido , Recém-Nascido Prematuro , Ligadura/métodos , Pneumopatias/epidemiologia , Pneumotórax , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Tempo para o Tratamento
16.
PLoS One ; 15(12): e0243314, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33270748

RESUMO

Musculoskeletal (MSK) injuries are one of the most frequent reason for pain-related evaluation in the emergency department (ED) in children. There is still no consensus as to what constitutes the best analgesic for MSK pain in children. However, ibuprofen is reported to be the most commonly prescribed analgesic and is considered the standard first-line treatment for MSK injury pain in children, even if it is argued that it provides inadequate relief for many patients. The purpose of this study was to review the most recent literature to assess the efficacy of ibuprofen for pain relief in MSK injuries in children evaluated in the ED. We performed a systematic review of randomized controlled trials on pharmacological interventions in children and adolescents under 19 years of age with MSK injuries according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The primary outcome was the risk ratio for successful reduction in pain scores. Six studies met the inclusion criteria and provided data on 1028 children. A meta-analysis was not performed since studies were not comparable due to the different analgesic treatment used. No significant difference in term of main pain score reduction between all the analgesics used in the included studies was noted. Patients who received oral opioids had side effects more frequently when compared to children who received ibuprofen. The combination of effect on pain relief and tolerability would suggest ibuprofen as the initial drug of choice in providing relief from mild-to-moderate MSK pain in children in the ED. The results obtained in this review and current research suggest that there's no straightforward statistically significant evidence of the optimal analgesic agent to be used. However, ibuprofen may be preferable as the initial drug of choice in providing relief from MSK pain due to the favorable combination of effectiveness and safety profile. In fact, despite the non-significant pain reduction as compared to children who received opioids, there are less side effect associated to ibuprofen within studies. The wide range of primary outcomes measured in respect of pain scores and timing of recorded measures warrants a future standardization of study designs.


Assuntos
Analgésicos não Narcóticos/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Ibuprofeno/uso terapêutico , Dor Musculoesquelética/tratamento farmacológico , Manejo da Dor , Ferimentos e Lesões/tratamento farmacológico , Adolescente , Adulto , Analgésicos não Narcóticos/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Criança , Feminino , Humanos , Ibuprofeno/efeitos adversos , Masculino , Dor Musculoesquelética/fisiopatologia , Ferimentos e Lesões/fisiopatologia
17.
Dermatol Online J ; 26(11)2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-33342182

RESUMO

Aquagenic wrinkling of the palms (AWP) is a rare, acquired condition of the skin, defined by transient rapidly developing white to translucent papules on palms and/or soles after brief exposure to water. Aquagenic wrinkling of the palms is associated with cystic fibrosis (CF). Therefore, the diagnosis of AWP can be important. Etiopathogenesis of AWP is still unclear. Treatment is often unsatisfactory and can be very challenging. This article contributes to the knowledge of AWP as we describe two new cases of aquagenic wrinkling of the palms: one patient with familial history of CF and one patient with AWP that was presumed to be induced by use of non-steroidal anti-inflammatory drugs. In addition, we present a review of the literature on drug-induced AWP.


Assuntos
Mãos/patologia , Pele/patologia , Adolescente , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Inibidores de Ciclo-Oxigenase 2/efeitos adversos , Feminino , Humanos , Ibuprofeno/efeitos adversos , Imersão , Lactonas/efeitos adversos , Masculino , Sulfonas/efeitos adversos , Água
18.
Orv Hetil ; 161(50): 2104-2106, 2020 12 13.
Artigo em Húngaro | MEDLINE | ID: mdl-33310923

RESUMO

Összefoglaló. A koronavírus-fertozés 2019 végén indult útjára, lassan a Föld teljes lakosságát eléro pandémiaként. Egy olyan kórokozóról van szó, amely ilyen nagy számú megbetegedést még nem okozott, ezért annak természetes lefolyásáról, a szövodmények kialakulásáról és a kezelési lehetoségekrol még keveset tudunk. Ennek következtében a kezdetben megjelent információk nagyon felületesek voltak, a következtetések nemritkán tévútra vezették mind az orvosokat, mind a betegeket. Az adatok gyarapodásával azonban egyre több kérdésre kapunk választ. Erre a folyamatra az egyik legreprezentánsabb példa az ibuprofén története, amely kezdetben tiltott, késobb turt terápiás szer volt, de ma már támogatott kezelési lehetoség a koronavírus-fertozésben. Orv Hetil. 2020; 161(50): 2104-2106. Summary. The coronavirus infection started in late 2019, as a pandemic slowly reaching the entire population of the earth. This pathogen has not yet caused such a large number of diseases, so little is known about its natural course, the development of complications, and treatment options. As a result, the information initially published was very superficial, and the conclusions often misled both physicians and patients. As the data grows, however, we get more and more questions answered. One of the most representative examples of this process is the history of ibuprofen, which was initially banned, thereafter tolerated, and is now a supported treatment option for coronavirus infection. Orv Hetil. 2020; 161(50): 2104-2106.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Ibuprofeno/efeitos adversos , Pneumonia Viral/tratamento farmacológico , Humanos , Ibuprofeno/uso terapêutico
19.
Pan Afr Med J ; 36: 350, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33224416

RESUMO

Introduction: fever is the primary symptom of most childhood illnesses and a cause of concern to their caregivers. The antipyretics commonly used to treat fever are ibuprofen and paracetamol. Most studies on the effectiveness of ibuprofen and paracetamol in treating fever in under-fives were conducted in Europe and North America with very few in African children. This study was aimed at assessing the effectiveness and safety of a single dose therapy of ibuprofen versus paracetamol for treating childhood fever in Nigeria. Methods: a randomized, controlled clinical trial was conducted in the University of Calabar Teaching Hospital, in Nigeria. A total of 140 eligible children aged 6-59 months with tympanic temperature of 38°C-40°C were enrolled, and 70 of them were assigned to one arm that received a single dose of ibuprofen (10mg/kg) and 70 had paracetamol (15mg/kg). After drug administration, the children were admitted and observed in the hospital for six hours during which period a half-hourly temperature measurement and monitoring for adverse events were done. Results: the overall result showed that ibuprofen had a better fever reducing effect compared to paracetamol. The proportion of afebrile children in the ibuprofen versus paracetamol group at 1.5-2.5 hours of administration of the drugs was statistically significant (p = 0.04). The adverse events of both drugs were mild and quite comparable with vomiting being the commonest. Conclusion: ibuprofen is more effective in the treating fever in under-fives compared to paracetamol. The adverse events of both drugs were mild and comparable.


Assuntos
Acetaminofen/administração & dosagem , Antipiréticos/administração & dosagem , Febre/tratamento farmacológico , Ibuprofeno/administração & dosagem , Acetaminofen/efeitos adversos , Antipiréticos/efeitos adversos , Temperatura Corporal/efeitos dos fármacos , Pré-Escolar , Feminino , Hospitais de Ensino , Humanos , Ibuprofeno/efeitos adversos , Lactente , Masculino , Nigéria , Vômito/induzido quimicamente
20.
Dermatol Ther ; 33(6): e14370, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33022801

RESUMO

In 2016, a case of seborrheic keratosis was successfully treated with diclofenac gel 3%. Diclofenac gel mechanism of action is most likely through induction of apoptosis. This study included 30 patients with multiple seborrheic keratosis. One lesion was treated with topical diclofenac sodium gel 1% and another lesion with topical ibuprofen gel applied twice daily for 8 weeks. Adobe photoshop CS6 was used to measure the surface area of the lesions before treatment and after 8 weeks. There was a highly statistically significant difference in the surface area of the lesions before and after treatment with topical diclofenac 1% gel (P = .001) but there was no statistically significant difference with topical ibuprofen gel (P = .057). There was a highly significant difference between the two treatment regimens as regard the percentage of change in surface area of the lesions, with higher change in the diclofenc 1% gel-treated group (P = .001). No patients complain from any side effect from either treatment.


Assuntos
Diclofenaco , Ceratose Seborreica , Administração Tópica , Anti-Inflamatórios não Esteroides/efeitos adversos , Diclofenaco/efeitos adversos , Géis , Humanos , Ibuprofeno/efeitos adversos , Ceratose Seborreica/diagnóstico , Ceratose Seborreica/tratamento farmacológico , Resultado do Tratamento
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