Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units

NCT03256903 | Completed Phase 3 DMC

• 1 other identifier: MR311-3502
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Acute Pain Due to Trauma

Keywords

Methoxyflurane; emergency; trauma pain; inhaled analgesia

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (5)

• Investigators and patients satisfaction

  30 min from start of administration

• Patient and investigators' fulfillment of expectations

  30 min from start of administration

• Patients' Global Impression of Change with the treatments

  Up until 30 minutes from STA

• Treatment cost of pain relief

  Up until 60 minutes from randomization

• Safety rates of treatment emergent adverse events

  Up until 14 days from STA

Study Arms (2)

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

Drug: Methoxyflurane

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.

Drug: Standard of care

Interventions

Methoxyflurane DRUG

Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.

Also known as: No other interventions

Methoxyflurane

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

Also known as: No other interventions

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients: ≥ 18 years of age
• Moderate to severe pain (NRS 0-10; \>=4) secondary to trauma
• Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay 12h)
• Conscious patient.
• Giving informed consent in writing

You may not qualify if:

• Hypersensitivity to methoxyflurane (MEOF) or any fluorinated anaesthetic.
• Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
• Patients who have a history of showing signs of liver damage after previous MEOF use or halogenated hydrocarbon anaesthesia
• Known clinically significant renal impairment
• Clinically evident cardiovascular instability
• Clinically evident respiratory depression
• Altered level of consciousness due to any cause, including head injury, drugs or alcohol
• Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
• Patients to be unable to understand the purpose of the study and perform self-assessments, following investigator's criteria.
• Participation in another clinical trial within 30 days prior to randomization

Sponsors & Collaborators

• Mundipharma Pharmaceuticals S.L.: lead
• Spanish Society for Emergency Medicine (SEMES): collaborator
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (14)

Hospital de Viladecans

Viladecans, Barcelona, 08840, Spain

Location

Hospital del Bierzo

Ponferrada, León, 24404, Spain

Location

Hospital Asepeyo Coslada

Coslada, Madrid, 28823, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Gernika-Lumo

Gernika-Lumo, Vizcaya, 48300, Spain

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

SUMMA - Comunidad de Madrid

Madrid, 28045, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Campo Grande

Valladolid, 47006, Spain

Location

Complejo Asistencial de Zamora

Zamora, 49022, Spain

Location

Related Publications (1)

• 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.

  PMID: 31623936 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

Methoxyflurane; Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alberto Borobia, MD, PhD

  La Paz University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Phase IIIb open randomized clinical trial

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: August 22, 2017
• Study Start: July 7, 2017
• Primary Completion: March 6, 2018
• Study Completion: July 31, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

ES (14)