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
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®.
Summary of results:
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.Rationale and background
Clinical studies involving IV bolus administration of diclofenac sodium showed potentially higher Cmax levels (peak level of the medication in the blood) compared to other IV diclofenac products, raising concerns regarding the potential for increased incidence of adverse events. Therefore, a post-authorisation safety study was proposed by the marketing authorisation holder to examine utilisation and safety of IV bolus formulation of diclofenac sodium for the prevention or treatment of post-operative pain.Aim of the study
To assess the utilisation and safety of IV bolus formulation of diclofenac sodium for use in the prevention and treatment of post-operative pain in the UK secondary care setting.Study method
Prescribers were recruited via UK Clinical Research Networks. Eligible patients were adults (≥18 years) prescribed diclofenac sodium for IV bolus administration. Information was extracted from patient’s medical records onto data collection forms and included demographics, details on drug utilisation and any adverse events reported.Results
A total of 1592 patients were recruited between 26th January 2022 and 31st December 2024. The majority of patients were female (58.2%), with the highest proportion of females and males aged between 51-60 years (n= 327; 20.5%). Most patients (94.7%) were treated for pain prevention. Over half (56.3%) of patients had one or more disorders listed as either a contraindication or special warnings and precautions in the Summary of Product Characteristics (SmPC). A total of 359 adverse events were reported in 152 patients (9.5% of the total cohort). Adverse events considered to be related to the treatment of a reported event were excluded. The remaining 297 adverse events were classified as non-serious (n=237) or serious (n=60). The most frequently reported adverse events were pain (2.6% of the total cohort), vomiting (1.0% of the total cohort) and nausea (0.9% of the total cohort). The adverse events assessed as serious were reported in 43 patients (2.7% of the total cohort). The highest incidence of any serious adverse event was 0.5% (urinary retention).Conclusions
Results from this study show a large proportion of patients receiving diclofenac sodium were reported to have either a contraindication or special warnings and precautions for use. This may reflect either a lack of prescriber awareness of prescribing guidelines, or the individual benefit risk assessment made by the prescriber. The most frequent adverse events were non serious and expected postoperatively. Whilst urinary retention was the most common serious adverse event reported, and is not listed in the SmPC, it is acknowledged to be commonly observed in the postoperative setting. The study design facilitated the assessment of a diverse patient population managed by specialist HCPs in secondary care, yielding a level of data fidelity not achievable with routinely collected data sources.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