Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children - The MAGPIE trial (MEOF-002): Study protocol for a randomised controlled trial
Files in This Item:
|Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children-the MAGPIE trial (MEOF-002) st.pdf||1.43 MB||Adobe PDF||Download|
|Title:||Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children - The MAGPIE trial (MEOF-002): Study protocol for a randomised controlled trial||Authors:||Hartshorn, Stuart; Barrett, Michael; Lyttle, Mark D.; et al.||Permanent link:||http://hdl.handle.net/10197/11776||Date:||4-Jul-2019||Online since:||2020-12-01T17:32:01Z||Abstract:||Background: Pain from injuries is one of the commonest symptoms in children attending emergency departments (EDs), and this is often inadequately treated in both the pre-hospital and ED settings, in part due to challenges of continual assessment and availability of easily administered analgesic options. Pain practices are therefore a key research priority, including within the field of paediatric emergency medicine. Methoxyflurane, delivered via a self-administered Penthrox® inhaler, belongs to the fluorinated hydrocarbon group of volatile anaesthetics and is unique among the group in having analgesic properties at low doses. Despite over 30 years of clinical acute analgesia use, and a large volume of evidence supporting its safety and efficacy, there is a paucity of randomised controlled trial data for Penthrox®. Methods: This is an international multi-centre randomised, double-blind, placebo-controlled phase III trial assessing the efficacy and safety of methoxyflurane delivered via the Penthrox® inhaler for the management of moderate to severe acute traumatic pain in children and young people aged 6-17 years. Following written informed consent, eligible participants are randomised to self-administer either inhaled methoxyflurane (maximum dose of 2 × 3 ml) or normal saline placebo (maximum dose 2 × 5 ml). Patients, treating clinicians and research nurses are blinded to the treatment. The primary outcome is the change in pain intensity at 15 min after the commencement of treatment, as measured by the Visual Analogue Scale (VAS) or the Wong-Baker FACES® Pain Rating scale, with the latter converted to VAS values. Secondary outcome measures include the number and proportion of responders who achieve a 30% reduction in VAS score compared to baseline, rescue medication requested, time and number of inhalations to first pain relief, global medication performance assessment by the patient, clinician and research nurse, and evaluation of adverse events experienced during treatment and during the subsequent 14 ± 2 days. The primary analysis will be by intention to treat. The total sample size is 110 randomised and treated patients per treatment arm. Discussion: The Methoxyflurane AnalGesia for Paediatric InjuriEs (MAGPIE) trial will provide efficacy and safety data for methoxyflurane administered via the Penthrox® inhaler, in children and adolescents who present to EDs with moderate to severe injury-related pain. Trial registration: EudraCT, 2016-004290-41. Registered on 11 April 2017. ClinicalTrials.gov, NCT03215056. Registered on 12 July 2017.||Funding Details:||Medical Developments International Limited||Type of material:||Journal Article||Publisher:||Springer||Journal:||Trials||Volume:||20||Issue:||1||Copyright (published version):||2019 the Authors||Keywords:||Pain; Methoxyflurane; Analgesics; Pain measurement; Treatment outcome; Nebulizers; Vaporizers; Penthrox®; Injury; Trauma; Randomised trial||DOI:||10.1186/s13063-019-3511-4||Language:||en||Status of Item:||Peer reviewed||ISSN:||1745-6215||This item is made available under a Creative Commons License:||https://creativecommons.org/licenses/by-nc-nd/3.0/ie/|
|Appears in Collections:||Medicine Research Collection|
Show full item record
If you are a publisher or author and have copyright concerns for any item, please email firstname.lastname@example.org and the item will be withdrawn immediately. The author or person responsible for depositing the article will be contacted within one business day.