Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma (STOP!)
This study has been completed.
Sponsor:
Medical Developments International Limited
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Pain Due to Trauma |
Drug: Methoxyflurane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Medical Developments International Limited:
Primary Outcome Measures:
- VAS Score [ Time Frame: Twenty Minutes ] [ Designated as safety issue: No ]The difference between treatment and placebo on the VAS pain score
Secondary Outcome Measures:
- 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
| Enrollment: | 300 |
| Study Start Date: | August 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Methoxyflurane |
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
|
| Placebo Comparator: Normal Saline |
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
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420159
Locations
| United Kingdom | |
| Barnsley District General Hospital | |
| Barnsley, United Kingdom, S75 2EP | |
| Birmingham Children's Hospital NHS Foundation Trust | |
| Birmingham, United Kingdom, B4 6NH | |
| Colchester General Hospital | |
| Colchester, United Kingdom, CO4 5JL | |
| James Cook University Hospital | |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Royal Victoria Infirmary | |
| Newcastle-upon-Tyne, United Kingdom, NE1 4LP | |
| Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus | |
| Nottingham, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
Medical Developments International Limited
ORION Clinical Services
Investigators
| Principal Investigator: | Frank M Coffey | Nottingham University Hospitals, Queen's Medical Centre Campus |
More Information
No publications provided
| Responsible Party: | Medical Developments International Limited |
| ClinicalTrials.gov Identifier: | NCT01420159 History of Changes |
| Other Study ID Numbers: | MEOF-001 |
| Study First Received: | August 11, 2011 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Medical Developments International Limited:
|
Pain Trauma Analgesia |
Additional relevant MeSH terms:
|
Wounds and Injuries Methoxyflurane Anesthetics, Inhalation Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013