Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units (InMEDIATE)
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|ClinicalTrials.gov Identifier: NCT03256903|
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Due to Trauma||Drug: Methoxyflurane Drug: Standard of care||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase IIIb open randomized clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Open Randomized Clinical Trial to Compare Pain Relief Between Methoxyflurane and Standard of Care for Treating Patients With Trauma Pain in Spanish Emergency Units.|
|Actual Study Start Date :||July 7, 2017|
|Actual Primary Completion Date :||March 6, 2018|
|Actual Study Completion Date :||July 31, 2018|
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
Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.
Other Name: No other interventions
Active Comparator: Standard of Care (SoC)
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.
Drug: Standard of care
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
Other Name: No other interventions
- Pain relief [ Time Frame: At baseline, 3, 5, 10, 15 and 20 minutes from STA ]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)
- Analgesia effectiveness [ Time Frame: Change from baseline to 3, 5, 10, 15, 20 and 30 min ]Difference between arms related to analgesia effectiveness
- Analgesia speed of action [ Time Frame: From time of randomization up to 20 minutes ]Difference between arms related to speed of action of analgesia for all patients
- Safety for patients with severe pain, treated with second or third step analgesics [ Time Frame: Up until 14 days from STA ]Difference between arms related to safety for patients with severe pain (NRS >7), treated with second or third step analgesics
- Patient-averaged summed pain intensity difference 15 min after STA [ Time Frame: from baseline to 3, 5, 10 and 15 minutes post dose ]Patient-averaged summed pain intensity difference 15 min after STA
- Pain Responders [ Time Frame: from baseline to 20 minutes post dose ]Pain Responders (with >30% pain relief compared to baseline) at 20 min
- Investigators and patients satisfaction [ Time Frame: 30 min from start of administration ]Investigators and patients satisfaction measured as convenience, treatment efficacy and adverse events, using NRS scales (0-10)
- Patient and investigators' fulfillment of expectations [ Time Frame: 30 min from start of administration ]Patient and investigators' fulfillment of expectations, measured with a 5 items Likert scale
- Patients' Global Impression of Change with the treatments [ Time Frame: Up until 30 minutes from STA ]Patients' Global Impression of Change with the treatments, measured using a 7 items Likert scale
- Treatment cost of pain relief [ Time Frame: Up until 60 minutes from randomization ]Treatment cost of pain relief, measured considering use of fungible material; need of nurse to administer iv treatments; time to discharge
- Safety rates of treatment emergent adverse events [ Time Frame: Up until 14 days from STA ]Safety rates of treatment emergent adverse events (TEAE) in both arms, including alterations in biochemical and blood count.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256903
|Hospital de Viladecans|
|Viladecans, Barcelona, Spain, 08840|
|Hospital del Bierzo|
|Ponferrada, León, Spain, 24404|
|Hospital Asepeyo Coslada|
|Coslada, Madrid, Spain, 28823|
|Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain, 28222|
|Hospital Álvaro Cunqueiro|
|Vigo, Pontevedra, Spain, 36312|
|Gernika-Lumo, Vizcaya, Spain, 48300|
|Hospital General de Alicante|
|Alicante, Spain, 03010|
|Hospital Universitario La Princesa|
|Madrid, Spain, 28006|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|SUMMA - Comunidad de Madrid|
|Madrid, Spain, 28045|
|Hospital La Paz|
|Madrid, Spain, 28046|
|Hospital Virgen del Rocío|
|Sevilla, Spain, 41013|
|Hospital Campo Grande|
|Valladolid, Spain, 47006|
|Complejo Asistencial de Zamora|
|Zamora, Spain, 49022|
|Study Director:||Alberto Borobia, MD, PhD||La Paz University Hospital|