Qizilbash, Nawab
Kataria, Himanshu
Jarman, Heather
Bloom, Ben
Bradney, Michelle
Oh, Maggie
Yee, Sue Anne
Roncero, Ana
Mendez, Ignacio
Pocock, Stuart
Funding for this research was provided by:
Medical Developments International Pty Limited
Article History
Received: 29 November 2022
Accepted: 3 August 2023
First Online: 30 August 2023
Declarations
:
: The studies were conducted in accordance with ethical principles of the Declaration of Helsinki, the European Directive 2001/83/EC and the guideline on good pharmacovigilance practices (GVP). The studies were also conducted in accordance with national and local laws of the countries where the study sites were located. According to local country-specific requirements, the protocol and associated documentation were submitted to all required relevant local approving bodies, which included Ethics committees and data protection bodies, as appropriate in each country. Written informed consent was obtained from all patients before enrolment. National ethics committee approval was obtained from the North of Scotland Research Ethics Committee (REC reference number: 16/NS/0057).
: To enable use of the retrospective data, the study was approved by the Medicines and Healthcare products Regulatory Agency’s Independent Scientific Advisory Committee (protocol number 19_195), and no separate ethical committee approval was required for use of this data. The protocol is available online.
: The manuscript has been written in accordance with STROBE [CitationRef removed], Good Pharmacoepidemiology Practice [CitationRef removed] and Good Publication Practice guidelines [CitationRef removed].
: Not applicable.
: MB, MO and SAY are employees of Medical Developments International Pty Limited which manufactures methoxyflurane (Penthrox®). NQ, IM, and AR work at OXON Epidemiology, which was funded by Medical Developments International Pty Limited to conduct all aspects of the study. The independent blinded adjudication committee members were paid for their review of cases by OXON Epidemiology. SP is a statistical consultant for OXON Epidemiology. The chief investigator and principal investigator´s sites were paid for inclusion and follow-up of patients via OXON Epidemiology. Rest all authors have no competing interest.