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| Name | Class |
|---|---|
| ORION Clinical Services | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxyflurane | Experimental |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane | Drug | Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Score | The difference between treatment and placebo on the VAS pain score | Twenty Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Medication | A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured | Up to a maximum of 6 hours |
| Time to pain relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank M Coffey | Nottingham University Hospitals, Queen's Medical Centre Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnsley District General Hospital | Barnsley | S75 2EP | United Kingdom | |||
| Birmingham Children's Hospital NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30863141 | Derived | Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019. | |
| 27567918 | Derived | Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27. |
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|
The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.
| Up to a maximum of 6 hours |
| Responder analysis | The number of responders will be defined | Up to a maximum of 6 hours |
| Safety Analysis | Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge | Up to 16 days |
| Birmingham |
| B4 6NH |
| United Kingdom |
| Colchester General Hospital | Colchester | CO4 5JL | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus | Nottingham | NG7 2UH | United Kingdom |
| 24743584 | Derived | Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D014947 | Wounds and Injuries |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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