Treatment of acute trauma-related pain in children and adolescents with methoxyflurane (Penthrox®) compared to placebo (MAGPIE): A randomised clinical trial
Abstract
IMPORTANCE
Methoxyflurane, an inhalational analgesic, has proven safety and efficacy in clinical trials and clinical practice. This double-blind, well-controlled study aimed to establish the benefit-risk of methoxyflurane in a paediatric population.
OBJECTIVE
To evaluate the safety and efficacy of methoxyflurane in children with minor trauma and acute pain presenting to emergency departments (ED).
DESIGN
Randomised, double-blind, multicentre, placebo-controlled study (MAGPIE).
SETTING
Conducted at 11 EDs in the UK and Ireland.
PARTICIPANTS
Participants aged from 6-<18 years of age with minor trauma and pain scores of 60-80 mm on a visual analogue scale (VAS), or 6-8 on a Wong Baker Pain Scale, were recruited.
INTERVENTIONS
Methoxyflurane 3 mL or placebo (normal saline, 5 mL) via a Penthrox® inhaler device, with a second inhaler upon request.
MAIN OUTCOME(S) AND MEASURE(S)
Primary: change in VAS pain intensity from baseline to 15-minutes in participants aged 9-<18 years (secondary: included the total Intent-To-Treat (ITT) population, aged 6-<18 years).
RESULTS
4513 patients screened, 249 participants randomised (127 methoxyflurane, 122 placebo), 192 treated (92 methoxyflurane, 100 placebo). Mean (standard deviation (SD)) age 11.1 (2.45) years; 108/192 (56 %) were male. At 15-minutes, the mean change from baseline in VAS was -20.0 mm (methoxyflurane) and -13.2 mm (placebo); least squares (LS) mean difference in 9-<18-year old's -6.8 mm [95 % CI -12.5 to -1.2 mm], p = 0.018,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 4,513 participants or records.
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