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| Name | Class |
|---|---|
| Spanish Society for Emergency Medicine (SEMES) | UNKNOWN |
| Spanish Clinical Research Network - SCReN | NETWORK |
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Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.
Open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in Spanish emergency units.
Methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain.
In Europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.
On the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects.
The main objective of this study is to assess Methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxyflurane | Experimental | Patients will be supplied with up to two inhalers containing 3 mL methoxyflurane. A member of the research team will train the patient to self-administer methoxyflurane |
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| Standard of Care (SoC) | Active Comparator | Patients will be treated following standard of care (SoC) of the hospital, for emergency relief of trauma and associated pain. Any kind of analgesia administered by any route will be valid. Only administration of one analgesic (or fixed combinations) at baseline will considered SoC. Other required analgesics will be considered rescue medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane | Drug | Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief, measured by numeric scale (0-10) | At baseline, 3, 5, 10, 15 and 20 minutes from STA |
| Analgesia effectiveness | Difference between arms related to analgesia effectiveness | Change from baseline to 3, 5, 10, 15, 20 and 30 min |
| Analgesia speed of action | Difference between arms related to speed of action of analgesia for all patients | From time of randomization up to 20 minutes |
| Safety for patients with severe pain, treated with second or third step analgesics | Difference between arms related to safety for patients with severe pain (NRS >7), treated with second or third step analgesics | Up until 14 days from STA |
| Patient-averaged summed pain intensity difference 15 min after STA | Patient-averaged summed pain intensity difference 15 min after STA | from baseline to 3, 5, 10 and 15 minutes post dose |
| Pain Responders | Pain Responders (with >30% pain relief compared to baseline) at 20 min | from baseline to 20 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Investigators and patients satisfaction | Investigators and patients satisfaction measured as convenience, treatment efficacy and adverse events, using NRS scales (0-10) | 30 min from start of administration |
| Patient and investigators' fulfillment of expectations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Borobia, MD, PhD | La Paz University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Viladecans | Viladecans | Barcelona | 08840 | Spain | ||
| Hospital del Bierzo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31623936 | Derived | Borobia AM, Collado SG, Cardona CC, Pueyo RC, Alonso CF, Torres IP, Gonzalez MC, Casal Codesido JR, Betegon MA, Barcela LA, Andicoechea AO, Testa AF, Colina JT, Dorribo AC, Del Arco Galan C, Martinez Avila JC, Lugilde ST, Carcas Sansuan AJ; InMEDIATE Investigators Group. Inhaled Methoxyflurane Provides Greater Analgesia and Faster Onset of Action Versus Standard Analgesia in Patients With Trauma Pain: InMEDIATE: A Randomized Controlled Trial in Emergency Departments. Ann Emerg Med. 2020 Mar;75(3):315-328. doi: 10.1016/j.annemergmed.2019.07.028. Epub 2019 Oct 14. |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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Phase IIIb open randomized clinical trial
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| Standard of care | Drug | Any kind of analgesia, administered by any route for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain |
|
|
Patient and investigators' fulfillment of expectations, measured with a 5 items Likert scale |
| 30 min from start of administration |
| Patients' Global Impression of Change with the treatments | Patients' Global Impression of Change with the treatments, measured using a 7 items Likert scale | Up until 30 minutes from STA |
| Treatment cost of pain relief | Treatment cost of pain relief, measured considering use of fungible material; need of nurse to administer iv treatments; time to discharge | Up until 60 minutes from randomization |
| Safety rates of treatment emergent adverse events | Safety rates of treatment emergent adverse events (TEAE) in both arms, including alterations in biochemical and blood count. | Up until 14 days from STA |
| Ponferrada |
| León |
| 24404 |
| Spain |
| Hospital Asepeyo Coslada | Coslada | Madrid | 28823 | Spain |
| Hospital Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital Gernika-Lumo | Gernika-Lumo | Vizcaya | 48300 | Spain |
| Hospital General de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| SUMMA - Comunidad de Madrid | Madrid | 28045 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Campo Grande | Valladolid | 47006 | Spain |
| Complejo Asistencial de Zamora | Zamora | 49022 | Spain |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |