AKIS registry study
Research type
Research Study
Full title
A registry study to assess the utilisation and safety of intravenous (IV) bolus formulation of Akis® (diclofenac sodium) for use in the prevention and treatment of post-operative pain in the UK secondary care setting
IRAS ID
271073
Contact name
Saad Shakir
Contact email
Sponsor organisation
Drug Safety Research Unit
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The aim of this study is to assess the utilisation and safety of an intravenous (IV) bolus formulation of Akis® in the UK secondary care (hospital) setting. Akis® is a non-steroidal anti-inflammatory drug (NSAID) and is used in the prevention and treatment of post-operative pain.
Prescribers/centres within the specialties of anaesthesia and surgery will be invited to participate in this study. Patients prescribed Akis® via IV administration will be identified and prescribers will be asked to abstract information from patient medical charts onto an electronic data collection form. This will be anonymised and will include information about the patient at the time the medication was given, treatment details and safety outcome information relating to the treatment period which was collected as part of routine clinical practice.
The study aims to recruit a minimum of 100 patients who have been prescribed the IV bolus formulation of Akis®.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/2010
Date of REC Opinion
2 Mar 2020
REC opinion
Further Information Favourable Opinion