PENTHROX-PASS
Research type
Research Study
Full title
Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom.
IRAS ID
198239
Contact name
Maggie Oh
Contact email
Sponsor organisation
Medical Developments International Limited
Clinicaltrials.gov Identifier
ID13041, ENCePP
Duration of Study in the UK
2 years, 1 months, 12 days
Research summary
This is an observational study of patients who were treated for moderate to severe pain in Accident and Emergency (A&E) or in Ambulances in the UK. The purpose of the study is to monitor the side effects of methoxyflurane, a pain killer recently authorised in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA requested that the marketing authorisation holder conducts this study with the primary objective of monitoring the risk of potential side effects on the liver. The study will be conducted in eight UK A&E centres in the UK which administer methoxyflurane to patients and are willing to participate. Patients who meet the eligibility criteria for the study will be invited to participate. Only patients who sign an informed consent form will be enrolled. Patients will be assigned to either the methoxyflurane or the comparative group, based on the drug that they have received in the A&E or in ambulance to manage their pain. Study patients will be followed up from the date of the admission to A&E for 12 weeks. During this period A&E staff dedicated to this study will contact the patient or hi/her GP to monitor his/her health with specific attention to potential liver or kidney side effects [hepatotoxicity, nephrotoxicity]. Patient data will be collected in anonymised form and will be loaded in the study electronic database. Data will include patient characteristics, such as age and gender, comorbidities, lifestyle parameters (e.g. alcohol abuse, obesity), presenting characteristics in A&E (e.g. crush injury, heavy bleeding, low blood pressure and diabetes). The frequency (number, percentage) of all cases of hepatotoxicity, or nephrotoxicity and any other detected side effects will be compared between patients treated with methoxyflurane and patients treated with other pain killers. The results of this analysis will be submitted to the MHRA.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0057
Date of REC Opinion
27 Jun 2016
REC opinion
Further Information Favourable Opinion