This study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital Emergency Department with a minor injury (known as trauma).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Barnsley District General Hospital
Barnsley, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
Colchester General Hospital
Colchester, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
VAS Score
The difference between treatment and placebo on the VAS pain score
Time frame: Twenty Minutes
Rescue Medication
A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured
Time frame: Up to a maximum of 6 hours
Time to pain relief
The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.
Time frame: Up to a maximum of 6 hours
Responder analysis
The number of responders will be defined
Time frame: Up to a maximum of 6 hours
Safety Analysis
Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge
Time frame: Up to 16 days
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Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus
Nottingham, United Kingdom