Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma

NCT01420159 | Completed Phase 3 DMC

• 1 other identifier: MEOF-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

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).

Conditions

Acute Pain Due to Trauma

Keywords

Pain; Trauma; Analgesia

Outcome Measures

Primary Outcomes (1)

• VAS Score

  The difference between treatment and placebo on the VAS pain score

  Twenty Minutes

Secondary Outcomes (4)

• Rescue Medication

  Up to a maximum of 6 hours

• Time to pain relief

  Up to a maximum of 6 hours

• Responder analysis

  Up to a maximum of 6 hours

• Safety Analysis

  Up to 16 days

Study Arms (2)

Methoxyflurane

EXPERIMENTAL

Drug: Methoxyflurane

Normal Saline

PLACEBO COMPARATOR

Drug: Methoxyflurane

Interventions

Methoxyflurane DRUG

Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.

Also known as: Penthrox

Methoxyflurane; Normal Saline

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Developments International Limited: lead
• ORION Clinical Services: collaborator

Study Sites (6)

Barnsley District General Hospital

Barnsley, S75 2EP, United Kingdom

Location

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, B4 6NH, United Kingdom

Location

Colchester General Hospital

Colchester, CO4 5JL, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30863141 DERIVED

• 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.

  PMID: 27567918 DERIVED

• 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.

  PMID: 24743584 DERIVED

MeSH Terms

Conditions

Pain; Wounds and Injuries; Agnosia

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Frank M Coffey

  Nottingham University Hospitals, Queen's Medical Centre Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

GB (6)