Protocol for a prospective observational study of adverse drug reactions of anti-epileptic drugs in children in the UK.

Background: Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects.

Anti-epileptic drug utilisation in paediatrics: a systematic review.

Objectives: This study aims to determine global anti-epileptic drug (AED) utilisation prevalence and describe utilisation trends in different countries.

Methods: Databases Embase (1980-May 2017), Medline (1946-May 2017) and PubMed were searched for original research on AED utilisation. All paediatric national or regional database studies and surveys were included.

Retrospective review of paediatric case reports of Stevens-Johnson syndrome and toxic epidermal necrolysis with lamotrigine from an international pharmacovigilance database.

Objectives: This study aims to characterise paediatric reports with lamotrigine (LTG) and Stevens-Johnson syndrome or toxic epidermal necrolysis (SJS/TEN), and to explore whether potential risk factors can be identified.

Design: This is a retrospective review of suspected adverse drug reaction (ADR) reports. Reported time from LTG start to SJS/TEN onset, indication for use and dose was explored.

Safety of antiepileptic drugs in children and young people: A prospective cohort study.

Purpose: This study aims to describe the incidence of adverse drug reactions (ADRs) in children receiving antiepileptic drugs (AEDs) and compare ADRs to the individual drugs when given as monotherapy.

Method: Paediatric patients (≤18 years old) were enrolled for this prospective observational study over a 6-month period, between September 2015 and March 2016. Adverse reactions to antiepileptic drugs (AEDs) were elicited at the time of enrolment and after 3 months using the Paediatric Epilepsy Side Effects Questionnaire.

Learning Lessons from Adverse Drug Reactions in Children.

Drug toxicity is, unfortunately, a significant problem in children both in the hospital and in the community. Drug toxicity in children is different to that seen in adults. At least one in 500 children will experience an adverse drug reaction each year.

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia.

Introduction: Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades.

Safety of Levetiracetam in Paediatrics: A Systematic Review.

Objective: To identify adverse events (AEs) associated with Levetiracetam (LEV) in children.

Methods: Databases 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.

Why do young children die in the UK? A comparison with Sweden.

Background: The UK has a high child mortality rate, whereas Sweden's is lower (under-five mortality rates of five and three, respectively, in 2011).We therefore wished to compare causes of death in young children aged <5 years in the two countries.

Methods: Under-five mortality data were obtained from the Office of National Statistics for each of the individual countries within the UK for 3 years (2006-2008).

Safety of lamotrigine in paediatrics: a systematic review.

Objectives: To identify adverse drug reactions associated with lamotrigine in children and compare the safety profile with other antiepileptic drugs.

Setting: Databases EMBASE (1974-April 2015), MEDLINE (1946-April 2015), PubMed and the Cochrane library for randomised controlled trials were searched for studies on safety of lamotrigine.

Participants: All studies involving paediatric patients aged ≤ 18 years who have received at least a single dose of lamotrigine with safety as an outcome measure were included.

A prospective study to assess the palatability of analgesic medicines in children.

Aim: This study examined children's opinions on the taste of three analgesic medicines: paracetamol, ibuprofen and codeine.

Background: Many medicines for children are unpleasant and unacceptable. Research has shown that children's taste preferences differ to adults, in whom palatability is often tested.

Systematic review of safety in paediatric drug trials published in 2007.

Background: There is now greater involvement of children in drug trials to ensure that paediatric medicines are supported by sound scientific evidence. The safety of the participating children is of paramount importance. Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial.

A survey of Canadian medical student attitudes towards the ethics of pediatric clinical trials: are they different from Canadian and British health care professionals?

Background: Due to ethical concerns and constraints inherent to research in children, the conduct of clinical trials in children has often been difficult. The views of medical professionals and trainees towards conducting clinical trials in children have been largely unexplored and are potentially important towards working to increase the number of appropriate trials conducted in children.

Objective: To explore the views of Canadian medical school trainees towards paediatric clinical trials and to compare these views with that of an earlier pilot study conducted amongst Canadian and British health care professionals.

A systematic review of pharmacokinetics studies in children with protein-energy malnutrition.

Objective: protein energy malnutrition (PEM) is a nutritional problem affecting many children world-wide. Its association with a wide spectrum of infections necessitates multiple drug therapies. A systematic review was performed to determine the effects of PEM on drug pharmacokinetics.

A systematic review of paediatric randomised controlled drug trials published in 2007.

Objective: To elucidate the current situation of randomised drug trials involving the paediatric population.

Methods: Systematic review of paediatric randomised controlled trials of medicinal products published in 2007. Three major databases were searched with validated search strategies; Medline, Embase and Cochrane Central Register of Controlled Clinical Trials.

Published pediatric randomized drug trials in developing countries, 1996-2002.

Background: The greatest burden of disease in children lies in the developing world; however, previous reviews have suggested that few randomized controlled trials (RCTs) involving children take place in developing countries. Children in developing countries deserve the same standard of medicines as those in developed countries, i.e.

Randomized controlled trial of the intraligamental use of a local anaesthetic (lignocaine 2%) versus controls in paediatric tooth extraction.

Background: Children still experience pain upon waking following dental extraction under general anaesthesia. Local anaesthetic has been shown to reduce this pain, but needs to be administered via a method that causes minimum injury or distress to the child.

Aim: This study aims to evaluate the use of intraligamental injection of local anaesthetic, under general anaesthesia prior to the extraction of the tooth, for postoperative pain control in children aged 2-5 years.

What motivates British parents to consent for research? A questionnaire study.

Background: Informed consent is the backbone of a clinical trial. In children this is given by their parents. There have been many studies in the neonatal population but little is known about the views of the parents of infants and young children from within the United Kingdom.