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

Acute Pain Due to Trauma Clinical Trial

— InMEDIATE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256903
• Other study ID #: MR311-3502
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Mundipharma Pharmaceuticals S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: July 31, 2018
• Est. primary completion date: March 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Emergencies
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Asepeyo Coslada	Coslada	Madrid
Spain	Hospital Gernika-Lumo	Gernika-Lumo	Vizcaya
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	SUMMA - Comunidad de Madrid	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital del Bierzo	Ponferrada	León
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Campo Grande	Valladolid
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital de Viladecans	Viladecans	Barcelona
Spain	Complejo Asistencial de Zamora	Zamora

Sponsors (3)

Lead Sponsor	Collaborator
Mundipharma Pharmaceuticals S.L.	Spanish Clinical Research Network - CAIBER, Spanish Society for Emergency Medicine (SEMES)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analgesia effectiveness	Difference between arms related to analgesia effectiveness	Change from baseline to 3, 5, 10, 15, 20 and 30 min
Primary	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
Primary	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
Primary	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
Primary	Pain Responders	Pain Responders (with >30% pain relief compared to baseline) at 20 min	from baseline to 20 minutes post dose
Secondary	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
Secondary	Patient and investigators' fulfillment of expectations	Patient and investigators' fulfillment of expectations, measured with a 5 items Likert scale	30 min from start of administration
Secondary	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
Secondary	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
Secondary	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