Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma

NCT03798899 | Completed Phase 4

• 2 other identifiers: MR311-45012017-004469-28
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 8

Brief Summary

A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief

  Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain

  through study completion, maximum of 2 hours

Secondary Outcomes (23)

• Duration between the start of study treatment (T0) and pain relief reported by the patient

  through study completion, maximum of 2 hours

• Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0

  baseline to 5, 10, 15, 20 and 30 minutes

• Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0

  baseline to 5, 10, 15, 20 and 30 minutes

• Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0

  baseline to 5, 10, 15, 20 and 30 minutes

• Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0

  baseline to 5, 10, 15, 20 and 30 minutes

Study Arms (2)

Penthrox® (Methoxyflurane)

EXPERIMENTAL

Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia. Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.

Drug: Methoxyflurane

Normal Saline

PLACEBO COMPARATOR

Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia. Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.

Drug: Normal Saline

Interventions

Methoxyflurane DRUG

PENTHROX 3mL inhalation vapour, liquid

Also known as: Penthrox®

Penthrox® (Methoxyflurane)

Normal Saline DRUG

Placebo

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 or older
• Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
• Patients admitted to the emergency department due to a trauma
• Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of admission to emergency departments.
• Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.

You may not qualify if:

• Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
• Impaired consciousness according to the investigator regardless of the cause, including head trauma or drug or alcohol consumption;
• Acute medicinal or alcohol intoxication, according to the investigator;
• Pregnant woman or woman at risk of pregnancy and not using highly effective contraception methods or known lactation;
• Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
• Treatment with nitrous oxide within 5 hours before presentation at the emergency department;
• Use of analgesics for chronic pain;
• Prior use of Penthrox®;
• Use of an investigational product one month before presentation at the emergency department;
• Hypersensitivity to Penthrox® or any other fluoridated anesthetic;
• History of signs of hepatic lesions after use of methoxyflurane or after anaesthesia by a halogenated hydrocarbon;
• Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;
• Clinical evidence of respiratory depression according to the investigator;
• Clinical evidence of cardiovascular instability according to the investigator;
• Clinical renal or hepatic damage, according to the investigator, pre-existing or known;

Sponsors & Collaborators

• Mundipharma SAS: lead
• AXONAL: collaborator
• Exystat: collaborator

Study Sites (8)

CH Annecy Genevois

Annecy, 74374, France

Location

GH Carnelle Porte de l'Oise

Beaumont-sur-Oise, 95260, France

Location

Hôpital Avicenne - APHP

Bobigny, 93000, France

Location

CHRU Lille

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hospice civil de Lyon

Pierre-Bénite, 69495, France

Location

CH René Dubos

Pontoise, 95300, France

Location

CHU Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Methoxyflurane; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• A Ricard-Hibon, Dr

  CHG Pontoise / SAMU 95

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 10, 2019
• Study Start: May 14, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

FR (8)