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

Health Conditions
  • Acute Pain Due to Trauma
Completed
Recruitment Status
NCT01420159
Primary Trial ID Number
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).
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
Research Question
  • 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).
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
12 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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.
Interventions
Drug; Methoxyflurane; Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.; [Methoxyflurane, Normal Saline]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
STOP!
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
Secondary Trial Identifying Number
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Website
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Study Funded By
Medical Developments International Limited
Funder Type
Sorry, this information is not available
Study Sponsored By
Medical Developments International Limited
Study Also Sponsored By
ORION Clinical Services
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

11 Aug 2011

Last Updated

30 Oct 2012

Date Record Refreshed on UKCTG

31 Jul 2015