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

This study has been completed.
Sponsor:
Collaborator:
ORION Clinical Services
Information provided by (Responsible Party):
Medical Developments International Limited
ClinicalTrials.gov Identifier:
NCT01420159
First received: August 11, 2011
Last updated: October 30, 2012
Last verified: October 2012

August 11, 2011
October 30, 2012
August 2011
July 2012   (final data collection date for primary outcome measure)
VAS Score [ Time Frame: Twenty Minutes ] [ Designated as safety issue: No ]
The difference between treatment and placebo on the VAS pain score
Same as current
Complete list of historical versions of study NCT01420159 on ClinicalTrials.gov Archive Site
  • Rescue Medication [ Time Frame: Up to a maximum of 6 hours ] [ Designated as safety issue: No ]
    A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured
  • Time to pain relief [ Time Frame: Up to a maximum of 6 hours ] [ Designated as safety issue: No ]
    The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.
  • Responder analysis [ Time Frame: Up to a maximum of 6 hours ] [ Designated as safety issue: No ]
    The number of responders will be defined
  • Safety Analysis [ Time Frame: Up to 16 days ] [ Designated as safety issue: Yes ]
    Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Pain Due to Trauma
Drug: Methoxyflurane
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Other Name: Penthrox
  • Experimental: Methoxyflurane
    Intervention: Drug: Methoxyflurane
  • Placebo Comparator: Normal Saline
    Intervention: Drug: Methoxyflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01420159
MEOF-001
Yes
Medical Developments International Limited
Medical Developments International Limited
ORION Clinical Services
Principal Investigator: Frank M Coffey Nottingham University Hospitals, Queen's Medical Centre Campus
Medical Developments International Limited
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP