Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute... | Completed
Efficacy and Safety of Methoxyflura... | Completed
Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma
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Trial Source

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Medical Conditions
  • Acute Pain Due to Trauma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01420159
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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).
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Methoxyflurane

Study Arm Groups : Methoxyflurane, Normal Saline

Intervention Type
See Interventions above
Primary Outcome Measures
    VAS Score; Twenty Minutes
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
12 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne
England
NE1 4LP
Nottingham
NG7 2UH
Rheumatology Department; Barnsley Hospital NHS Foundation Trust
Barnsley
S75 2EP
Birmingham
B4 6NH
Colchester General Hospital
Mile End
CO4 5JL
Middlesbrough
TS4 3BW
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • ORION Clinical Services
Other Study ID Numbers
MEOF-001
Sponsor(s)
Medical Developments International Limited
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Jul 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

11 Aug 2011

Last Updated

30 Oct 2012