PERUKI research studies currently enrolling

CAP-IT: Community-Acquired Pneumonia: A randomised controlled Trial

CAP-IT Amoxicillin is the drug of choice for treatment of community-acquired pneumonia (CAP) in children according to the British Thoracic Society (BTS) guideline and several international guidelines. However, a better understanding of the relationship between dose and duration of antibiotic exposure and the development of resistance as well as the impact on the clinical outcomes would make it possible to formulate improved evidence-based treatment recommendations for paediatric CAP. Several current guidelines for the management of CAP identify the lack of evidence on which to base duration and dosing treatment strategies in children in the resource-rich setting. CAP-IT is a double blind placebo controlled factorial trial and aims to determine if lower doses of amoxicillin are non-inferior to higher doses, and whether a shorter duration of amoxicillin treatment is non-inferior to longer duration in children aged 1-5 with clinically diagnosed CAP. The CAP-IT trial is due to open in 15 PERUKI sites and started recruitment in February 2017. See www.capitstudy.org.uk and @capitstudy

Pain management of paediatric minor injuries – service evaluation & feasibility project

Pain assessment and analgesia administration in children is a core competence for emergency staff.  The aim of this feasibility project is to establish current practice for the assessment and management of pain in children and young people presenting to PERUKI Emergency Departments with minor injuries.  

The project consists of two parts:

Part 1: Audit & Service Evaluation

Prospective identification (and retrospective data collection) for all children attending participating sites with pain associated with minor trauma, during a 7-day period.

Part 2: Site Survey

Completion of an online survey regarding the use of pain score tools, pain protocols and guidelines for specific analgesic agents within each participating site.

The results of this project will also inform the MAGPIE study, due to start later in 2017.

THE Children’s Radius Acute Fracture Fixation Trial (CRAFFT)

The UK is more interventional than many countries, including the USA, in the treatment of distal radius fractures in children. Standard UK treatment is surgical correction, whilst others often follow a non-operative approach. There is low quality evidence that these fractures heal well and completely correct themselves without surgery in children under 11 years old, even if bones are initially displaced. There is a clear and pressing need to inform patients about benefits or otherwise of treatment options, and a need to inform commissioners regarding the costs to the NHS and society. CRAFFT (The Children’s Radius Acute Fracture Fixation Trial) is a multi-centre prospective randomized non-inferiority trial of surgical reduction versus non-surgical casting for severely displaced off-ended distal radius fractures (metaphyseal or Salter Harris) in children aged 4 to 10 years. In this cross-network (PERUKI & BSCOS) study the primary outcome is the Patient Reported Outcomes Measurement Information System Upper Extremity Score for Children (PROMIS UE). The trial started in 2019 and recruitment will finish in 2023. The sample size is 750 children.

rotavirus and febrile convulsions (rvfits)

rvfitsInternational studies have identified a potential 20-40% reduction in the risk of seizures in those who had been vaccinated against rotavirus compared to those who had not.  In England, Wales and Scotland, rotavirus vaccination was rolled out in July 2013, with excellent uptake (90% of applicable population) and has been extremely effective at preventing ED attendance and admission for gastroenteritis.  However using Hospital Episode Statistics for England we have not been able to detect a change in the number of children being admitted with seizures.  Our hypothesis is that ED attendance data will provide the most sensitive method of detecting changes in paediatric epidemiology, with PERUKI able to facilitate a rapid large-scale multicentre approach.  Demonstrating the efficacy of this method could allow the development of a more standardized system for assessing other known or hypothesised vaccine side effects, as well as other conditions amenable to this methodology.  This multicentre study will use interrupted time series analysis to combine seizure, gastroenteritis and croup attendance rates across the PERUKI network to assess if the introduction of rotavirus vaccine can demonstrate an effect on seizure attendances in the UK.

MAGPIE Methoxyflurane is an inhaled analgesic and anaesthetic agent.  As an analgesic agent (at low doses), methoxylurane has been used extensively within a number of ambulance services, Emergency Departments and armed forces in Australia and New Zealand, including more than 20 years of administration via the Penthrox inhaler (Medical Developments International).  Clinical indications include both traumatic and non-traumatic acute pain, and procedural pain, in both adult and paediatric populations.

Key advantages of Penthrox include rapid onset of analgesia, few minor side effects, compact size and ease of use, short recovery time and no requirement for opioid-related post-treatment monitoring.

Since October 2015, Penthrox has been licensed for use in the UK and Ireland for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.

MAGPIE is a regulatory study which aims to demonstrate the clinical efficacy and safety of Penthrox in children and young people within the UK and Ireland, in order to extend the current license to the paediatric population.  It is a randomised, double-blind, placebo controlled study which will evaluate the safety and efficacy of Penthrox of acute pain associated with minor trauma in patients between the ages of 6 and 18 years.

9 PERUKI sites are participating in this study, with recruitment due to commence in July 2017.

Methoxy-flurane AnalGesia for Paediatric InjuriEs (MAGPIE)
Variations in care of young children presenting with skull fractures - the Raise study

VARIATIONS IN CARE OF CHILDREN PRESENTING WITH SKULL FRACTURES Skull fractures in young children often generate concern regarding the mechanism of injury and possible non-accidental injury (NAI).

The Royal College of Radiology guidance recommends a skeletal survey and CT head in children under 2 years of age if abusive head injury is suspected. We hypothesise that where skull fractures are found, there are regional and interdepartmental variations in practice with regards to radiological investigations carried out, safeguarding referrals, assessments, and follow up.

This service evaluation study will create an extensive database of children less than 2 years old presenting with skull fractures (with or without intracranial involvement), the purported mechanisms for the injury, the investigative processes undertaken and subsequent follow-up.  The study aims to produce evidence to inform guidance, and enhance clinical decision making in determining the likelihood of NAI as the underlying cause for the skull fracture.

Data collection from several PERUKI sites has been completed, and following presentation at conference, further outputs are expected in 2019.

THE Force study (buckle fracture management)

force

Torus (buckle) fractures of the wrist are the most common fractures in children. They result from injury to growing bones and account for 500,000 UK emergency attendances annually. Torus fractures have a very low risk of complications and universally heal well.

There is considerable variation in the management of torus fractures. Treatment varies from the use of a removable rigid splint, to plaster cast immobilisation, to more flexible splints or soft bandages.


The key differences relating to the degree of immobilisation provided, and the follow-up required. Non-removable rigid casts are no longer recommended for the treatment of these injuries. Removable splints immobilise the wrist and may provide the best pain relief. Soft bandaging restricts movement the least and may encourage early function, but concern remains about pain and the potential for complications, despite evidence to the contrary. The National Institute for Health and Care Excellence (NICE) guidelines made recommendations on the management of these injuries and concluded that bandaging was probably the best treatment approach, due the convenience, adequate pain control and the ability to promote early function, though asked whether any treatment is really necessary. NICE also recommended that no follow-up of these injuries is necessary because they are almost always complication free and they universally heal well. However, there is variable follow-up at different hospitals.

 

The aim of this trial is to assess effectiveness of the optional use of soft bandage and immediate discharge, compared to rigid splint immobilisation.

Recruitment is due to start in winter 2018

adolescent trauma

Adolescent morbidity and mortality is heavily influenced by risk taking; while there has been a small reduction in mortality over the last 20 years this is to a much lesser extent than is seen in other ages. This study aims to interrogate the Trauma Audit Research Network (TARN) database to answer key questions regarding adolescent trauma. Specific areas of focus will be epidemiology, injury patterns (in comparison to paediatric/adult patterns), and outcomes based on type of institution. These findings will represent the first time this has been evaluated in the setting of PERUKI, and will shape prevention strategies and inform service development. This study also represents the first collaboration between TARNlet and PERUKI, opening the door to gaining a richer understanding of trauma in Children and Young People.