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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-01-10

No results posted yet for this study

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

Interventions

DRUG

Methoxyflurane

PENTHROX 3mL inhalation vapour, liquid

DRUG

Normal Saline

Placebo

Sponsors & Collaborators

  • AXONAL

    collaborator UNKNOWN

  • Exystat

    collaborator OTHER

  • Mundipharma SAS

    lead INDUSTRY

Principal Investigators

  • A Ricard-Hibon, Dr · CHG Pontoise / SAMU 95

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2018-12-20
Completion
2018-12-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798899 on ClinicalTrials.gov