Clinical trial NCT01420159: Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma
Official title: A Randomised, Double Blind, Multi-centre, Placebo Controlled Study to Evaluate the Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Patients Presenting to an Emergency Department With Minor Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain Due to Trauma
Keywords: Pain
Trauma
Analgesia
Lead sponsor: Medical Developments International Limited
Sponsor class: INDUSTRY
Collaborators: name: ORION Clinical Services
First posted: 2011-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf.
* Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
* Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.

Exclusion Criteria:

* Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit.
* Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
* Unable to provide written informed consent.
* Known pregnancy or lactation
* Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
* Treatment with any analgesic agent within 5 hours prior to presentation to ED (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ED).
* Current ongoing use of analgesics for chronic pain.
* Use of an investigational product within one month prior to presentation to ED.
* Known personal or familial hypersensitivity to fluorinated anaesthetics.
* Known personal or familial history of malignant hyperthermia.
* Clinically significant respiratory depression.
* Use of methoxyflurane in the previous 4 weeks.
* Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician.
* Clinically significant cardiovascular instability.

Primary outcomes:
measure: VAS Score
timeFrame: Twenty Minutes
Secondary outcomes:
measure: Rescue Medication
timeFrame: Up to a maximum of 6 hours
measure: Time to pain relief
timeFrame: Up to a maximum of 6 hours
measure: Responder analysis
timeFrame: Up to a maximum of 6 hours
measure: Safety Analysis
timeFrame: Up to 16 days
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley District General Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS Foundation Trust
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus
Study officials:
affiliation: Nottingham University Hospitals, Queen's Medical Centre Campus
name: Frank M Coffey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019.
citation: Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.
citation: Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.