Safety of ceftriaxone in paediatrics: a systematic review protocol.
Ontology highlight
ABSTRACT: Introduction
Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups.Methods and analysis
MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen.Ethics and dissemination
Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings.Prospero registration number
CRD42017055428.
SUBMITTER: Zeng L
PROVIDER: S-EPMC5634450 | biostudies-literature | 2017 Aug
REPOSITORIES: biostudies-literature
Publications
Safety of ceftriaxone in paediatrics: a systematic review protocol.
Zeng Linan L Choonara Imti I Zhang Lingli L Xue Song S Chen Zhe Z He Miaomiao M
BMJ open 20170821 8
<h4>Introduction</h4>Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups.<h4>Methods and analysis</h4>MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will ...[more]
Similar Datasets
Project description:IntroductionAzithromycin is widely used in children not only in the treatment of individual children with infectious diseases, but also as mass drug administration (MDA) within a community to eradicate or control specific tropical diseases. MDA has also been reported to have a beneficial effect on child mortality and morbidity. However, concerns have been raised about the safety of azithromycin, especially in young children. The aim of this review is to systematically identify the safety of azithromycin in children of all ages.Methods and analysisMEDLINE, PubMed, Cochrane Central Register of Controlled Trials, Embase, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of azithromycin in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools, and The Joanna Briggs Institute Critical Appraisal tools will be used for quality assessment. Meta-analyses will be conducted to the incidence of ADRs from RCTs if appropriate. Subgroup analyses will be performed in different age and azithromycin dosage groups.Ethics and disseminationFormal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.Prospero registration numberCRD42018112629.
| S-EPMC6598555 | biostudies-literature
Project description:ObjectiveTo identify adverse events (AEs) associated with Levetiracetam (LEV) in children.MethodsDatabases EMBASE (1974-February 2015) and Medline (1946-February 2015) were searched for articles in which paediatric patients (?18 years) received LEV treatment for epilepsy. All studies with reports on safety were included. Studies involving adults, mixed age population (i.e. children and adults) in which the paediatric subpopulation was not sufficiently described, were excluded. A meta-analysis of the RCTs was carried out and association between the commonly reported AEs or treatment discontinuation and the type of regimen (polytherapy or monotherapy) was determined using Chi2 analysis.ResultsSixty seven articles involving 3,174 paediatric patients were identified. A total of 1,913 AEs were reported across studies. The most common AEs were behavioural problems and somnolence, which accounted for 10.9% and 8.4% of all AEs in prospective studies. 21 prospective studies involving 1120 children stated the number of children experiencing AEs. 47% of these children experienced AEs. Significantly more children experienced AEs with polytherapy (64%) than monotherapy (22%) (p<0.001). Levetiracetam was discontinued in 4.5% of all children on polytherapy and 0.9% on monotherapy (p<0.001), the majority were due to behavioural problems.ConclusionBehavioural problems and somnolence were the most prevalent adverse events to LEV and the most common causes of treatment discontinuation. Children on polytherapy have a greater risk of adverse events than those receiving monotherapy.
| S-EPMC4773020 | biostudies-literature
Project description:INTRODUCTION:Clown intervention may playing an important complementary role in paediatric care and recovery. However, data on its utility for symptom cluster management of hospitalised children and adolescents in acute and chronic disorders are yet to be critically evaluated. As clinicians strive to minimise the psychological burden during hospitalisation, it is important that they are aware of the scientific evidences available regarding clown intervention for symptom management. We aim to provide quality evidence for the effectiveness of clown intervention on symptom cluster management in paediatric inpatients, both in acute and chronic conditions. METHODS AND ANALYSIS:A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. MEDLINE, Web of Science, Cochrane Library, Science Direct, PsycINFO, CINAHL, LILACS and SciELO databases will be searched from January 2000 to December 2018. Primary outcomes will include measures related with the effect of clown intervention on symptom cluster of paediatric inpatients (anxiety, depression, pain, fatigue, stress and psychological, emotional responses and perceived well-being). Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the methodological appraisal of the studies will be assessed by the Jadad Scale as well as Cochrane Risk-of-Bias Tool for RCTs, and Risk-of-Bias In Non-Randomized Studies Tool for NRCTs. A narrative synthesis will be conducted for all included studies. Also, if sufficient data are available, a meta-analysis will be conducted. The effect sizes will be generated using Hedges' g score for both fixed and random effect models. I 2 statistics will be used to assess heterogeneity and identify their potential sources. ETHICS AND DISSEMINATION:As it will be a systematic review, without human beings involvement, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia. TRIAL REGISTRATION NUMBER:CRD42018107099.
| S-EPMC6347896 | biostudies-other
Project description:Many cancer patients experience leucopoenia during chemotherapy. Granulocyte- colony-stimulating factor (G-CSF) is used to treat chemotherapy-induced leucopoenia (CIL) but has various limitations. Clinical trials have indicated that acupuncture may prevent bone marrow suppression and increase leucocyte counts after chemotherapy. The objective of this review is to assess the efficacy and safety of acupuncture for treating CIL.This systematic review will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library, Medline, EMBASE, the China National Knowledge Infrastructure Database (CNKI), the Chinese Biomedical Literature Database (CBM), the Chinese Scientific Journal Database (VIP Database) and the Wanfang database from their inception to 1 January 2016. Other sources will also be searched including potential grey literature, conference proceedings and the reference lists of identified publications and existing systematic reviews. Two reviewers will independently search the databases, perform data extraction and assess the quality of studies. Data will be synthesised by either the fixed-effects or the random-effects model according to a heterogeneity test. White blood cell counts will be assessed as the primary outcome. Adverse effects, incidence of leucopoenia, quality of life and physical condition will be evaluated as secondary outcomes. RevMan V.5.3 will be employed for data analysis. The results will be expressed as risk ratios for dichotomous data and mean differences for continuous data.The protocol does not need ethics approval because individuals cannot be identified. The review will be reported in a peer-reviewed publication or at a relevant conference.CRD42015027594.
| S-EPMC4885439 | biostudies-other
Project description:BackgroundSafety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons.Methods/designWe will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus.DiscussionGlobally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be feasible among HIV-infected persons.Systematic review registrationPROSPERO CRD42014009794.
| S-EPMC4163552 | biostudies-literature
Project description:Introduction Functional constipation (FC) is a common digestive system disease, with an uptrend in morbidity and mortality, resulting in huge social and economic losses. Although the guidelines recommend lifestyle intervention as a first-line treatment, lifestyle intervention is not widely used in clinic. Inulin can be used as the basic material of functional food. Clinical studies have shown that inulin supplementation is associated with increased frequency of bowel movements, but has certain side effects. Therefore, the efficacy and safety of inulin in the treatment of FC need to be further evaluated. Methods and analysis We will search Medline, Web of Science, Embase, China National Knowledge Infrastructure Database, Wanfang Database and China Biomedical Literature Database. We will also search the China Clinical Trial Registry, the Cochrane Central Register of Controlled Trials and related conference summaries. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RevMan V.5.3.5 will be used for analysis. Ethics and dissemination This systematic review will evaluate the efficacy and safety of inulin supplementation for the treatment of FC. All included data will be obtained from published articles, there is no need for the ethical approval, and it will be published in a peer-reviewed journal. Due to lack of a new systematic review in this field, this study will combine relevant randomised controlled trials to better explore the evidence of inulin supplementation in the treatment of FC and guide clinical practice and clinical research. PROSPERO registration number CRD42020189234.
| S-EPMC8039257 | biostudies-literature
Project description:IntroductionRecurrent aphthous stomatitis (RAS) is a distressing symptom. There are many ways to treat RAS, such as pudilan anti-inflammatory oral liquid and doxycycline and laser therapy, but these take a long time to produce positive effects and compliance is low. Previous reviews of acupuncture treatment for RAS has been growing, but a systematic review is not available. To assess the efficacy and safety of acupuncture for the management of RAS.Methods and analysisThe following databases will be searched from their inception to 1 February 2020: PubMed, Embase, Cochrane Library, CINAHL, Chinese Biomedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure and Wanfang. The randomised controlled trials in English or Chinese associated with acupuncture for patients with RAS will be included. Eligible study conference abstracts and reference lists of manuscripts will also be searched. Two reviewers will select the studies, extract data independently. The Cochrane risk of bias tool will be used to assess the risk of bias for the studies. According to heterogeneity testing, data will be synthesised using a random-effects model. A meta-analysis will be performed using Rev Man V.5.3.5 statistical software for each outcome. Subgroup analysis and sensitivity analysis are planned according to clinical evidence. Mean difference or standardised mean difference for continuous data and risk ratio for dichotomous data will be calculated.Ethics and disseminationNo ethical approval is required. This protocol will not involve individual patient information and endangering participant rights. The results will be reported in a peer-reviewed journal or disseminated in relevant conferences.Osf registration numberDOI 10.17605/OSF.IO/QASUY.
| S-EPMC7542930 | biostudies-literature
Project description:BACKGROUND:Warm needle acupuncture (WNA) combines acupuncture and moxibustion, which is an integral part of the acupuncture therapy. Insomnia is a common sleep disorder, which affects sub-healthy people and patients with chronic disease. The clinical practice indicates that WNA has a therapeutic effect on insomnia. Here we will provide a protocol to explore the effectiveness and safety of WNA for insomnia. METHODS:We will search the randomized controlled trails (RCT) literatures of WNA for insomnia in 9 electronic databases, including 5 English databases [PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials (Cochrane Library), and WHO International Clinical Trials Registry Platform (TCTRP)] and 4 Chinese databases [Chinese National Knowledge Infrastructure (CNKI), Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database (CBM)]. Sleep quality value of the patient will be considered as the primary outcome and the secondary outcome will include biochemical, indicators total scores on the insomnia severity index, quality of life, adverse events caused by WNA, and changes of symptom in Traditional Chinese Medicine. The selection of the studies will be performed by EndnoteX7 software. All analyses will be conducted by using RevMan software V5.3. RESULT:This study will provide a rational synthesis of current evidences for warm needle acupuncture on insomnia. CONCLUSION:The conclusion of this study will provide evidence to judge the effectiveness and safety of WNA on insomnia. REGISTRATION:PROS-PERO CRD42018112645.
| S-EPMC6319996 | biostudies-other
Project description:IntroductionThe US Food and Drug Administration has withdrawn the bowel cleansing kit HalfLytely (PEG 3500) with 10 mg bisacodyl tablets due to an increased risk of ischaemic colitis compared with the same kit with only 5 mg bisacodyl. This is of interest in Canada given that the bowel cleansing kit Bi-Peglyte (PEG 3500) with 15 mg bisacodyl is currently approved for use. The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)-based and sodium-picosulfate-based products.Methods and analysisGiven the existing volume of the literature, the review will be conducted in two stages. Stage 1 will consist of a scoping exercise by searching MEDLINE, Embase and the Cochrane Library (up to 21 November 2017) to identify randomised controlled trials, quasirandomised studies and non-randomised studies in which any bowel cleanser regimens were compared among persons undergoing colonoscopy. The outcomes will be mapped to establish a listing of the studies and their comparisons and outcomes currently available in the literature. From this, a data synthesis plan will be determined. In stage 2, a systematic review with meta-analyses will be pursued, focused on the bowel cleanser comparisons and outcomes of interest identified in stage 1. Two reviewers will screen, extract and quality assess the articles. Outcomes of interest include ischaemic colitis, electrolyte imbalances and their consequences, seizures, bowel perforation and patient tolerability. If sufficient data exist and studies are of sufficient homogeneity, network meta-analyses (NMAs) will be performed.Ethics and disseminationEthics approval was not necessary due to study design. Updating the safety profile of bowel cleansers among the generally healthy population undergoing colonoscopy is pertinent given recent approval changes. This will be the first NMA within this population. Policy considerations may be reconsidered to minimise risk during bowel cleanser use.Prospero registration numberCRD42018084720.
| S-EPMC6020982 | biostudies-literature
Project description:BackgroundPublic safety occupations are well-recognized to be dangerous and stressful. Despite recent attention on post-traumatic stress injuries among public safety personnel, there has been considerably less attention paid to the ongoing ways in which the risks and requirements associated with those occupations shape family life, and how families respond and adapt to those lifestyle dimensions. This systematic review aims to understand how day-to-day family life is affected and shaped when a family member works in a public safety sector, such as fire, police, paramedic, corrections, and emergency communications.MethodsQualitative studies that examine the experiences of families or family members of public safety personnel will be included in this review, with no date or language restrictions. An initial search of Embase and CINAHL will be conducted, followed by an analysis of text words contained in the title and abstract, and of the index terms used to describe the articles. Databases to be searched for published studies include MEDLINE, Embase, Web of Sciences, CINAHL, PsycINFO, and Sociological Abstracts. Titles and abstracts will be screened by two independent reviewers. The full texts of selected studies will be assessed in detail, and findings and their illustrations will be extracted and aggregated. Any disagreements between the reviewers that arise at each stage will be resolved through discussion, or by a third reviewer. Further analysis of the synthesized findings will be informed by family systems theory.DiscussionThe ways that occupational risks and requirements shape family life have been better investigated within other high-risk occupation groups, which has led to productive advancements in organizational policies and supports in the respective sectors. An understanding of the experiences which typify family life ongoing within PSP sectors is a critical gap in the development of meaningful family-informed occupational initiatives and supports.Systematic review registrationSubmitted to PROSPERO for systematic review registration: CRD42020208126.
| S-EPMC8474829 | biostudies-literature