Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children—the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial

Autor: Sue Anne Yee, Stuart Hartshorn, Alan T. Irvine, Mark D Lyttle, Michael Barrett
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Male
Vaporizers
Time Factors
Nebulizers
Medicine (miscellaneous)
Injury
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Multicenter Studies as Topic
Medicine
Pharmacology (medical)
030212 general & internal medicine
Treatment outcome
Child
Pain Measurement
Randomized Controlled Trials as Topic
Analgesics
Pain measurement
lcsh:R5-920
Age Factors
Treatment Outcome
Paediatric
Female
Emergency Service
Hospital
lcsh:Medicine (General)
medicine.drug
Randomised trial
medicine.medical_specialty
Adolescent
Visual analogue scale
Analgesic
Pain
Placebo
Penthrox®
Trauma
03 medical and health sciences
Double-Blind Method
Methoxyflurane
Administration
Inhalation
Humans
Adverse effect
Intention-to-treat analysis
business.industry
Nebulizers and Vaporizers
Inhaler
United Kingdom
Clinical Trials
Phase III as Topic
Physical therapy
Wounds and Injuries
Analgesia
business
Ireland
030217 neurology & neurosurgery
Zdroj: Trials, Vol 20, Iss 1, Pp 1-13 (2019)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-019-3511-4
Popis: 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3511-4) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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