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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
Sponsor:
Collaborators:
Spanish Society for Emergency Medicine (SEMES)
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Alberto M. Borobia, Hospital Universitario La Paz

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.

Condition or disease Intervention/treatment Phase
Acute Pain Due to Trauma Drug: Methoxyflurane Drug: Standard of care Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase IIIb open randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methoxyflurane
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
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




Primary Outcome Measures :
  1. 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)

  2. Analgesia effectiveness [ Time Frame: Change from baseline to 3, 5, 10, 15, 20 and 30 min ]
    Difference between arms related to analgesia effectiveness

  3. 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

  4. 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

  5. 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

  6. Pain Responders [ Time Frame: from baseline to 20 minutes post dose ]
    Pain Responders (with >30% pain relief compared to baseline) at 20 min


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Known pregnant or likely to be pregnant women at the time of inclusion.
  • Clinically evident cardiovascular instability
  • Clinically evident respiratory depression
  • Patients taken any analgesic for the traumatic pain before inclusion
  • 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

Information from the National Library of Medicine

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


Locations
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Spain
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
Hospital Gernika-Lumo
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
Sponsors and Collaborators
Mundipharma Pharmaceuticals S.L.
Spanish Society for Emergency Medicine (SEMES)
Spanish Clinical Research Network - CAIBER
Investigators
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Study Director: Alberto Borobia, MD, PhD La Paz University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alberto M. Borobia, MD, PhD, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03256903    
Other Study ID Numbers: MR311-3502
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto M. Borobia, Hospital Universitario La Paz:
Methoxyflurane
emergency
trauma pain
inhaled analgesia
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Wounds and Injuries
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Methoxyflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs