Acute Pain Due to Trauma
Conditions
Keywords
Pain, Trauma, Analgesia
Brief 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).
Interventions
DRUGMethoxyflurane
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Sponsors
ORION Clinical Services
Medical Developments International Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score | Twenty Minutes | The difference between treatment and placebo on the VAS pain score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication | Up to a maximum of 6 hours | 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 | Up to a maximum of 6 hours | The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved. |
| Responder analysis | Up to a maximum of 6 hours | The number of responders will be defined |
| Safety Analysis | Up to 16 days | Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge |
Countries
United Kingdom
Outcome results
None listed