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

Acute Pain Due to Trauma Clinical Trial

— STOP!  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420159
• Other study ID #: MEOF-001
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2011
• Last updated: October 30, 2012
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Medical Developments International Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United Kingdom	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	Royal Victoria Infirmary	Newcastle-upon-Tyne
United Kingdom	Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Medical Developments International Limited	ORION Clinical Services

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Score	The difference between treatment and placebo on the VAS pain score	Twenty Minutes	No
Secondary	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	Up to a maximum of 6 hours	No
Secondary	Time to pain relief	The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.	Up to a maximum of 6 hours	No
Secondary	Responder analysis	The number of responders will be defined	Up to a maximum of 6 hours	No
Secondary	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	Up to 16 days	Yes