Multicentre, randomised, double-blind study assessing the efficacy and safety of Penthrox® combined with a standard analgesia (SoC) in comparison to a placebo combined with a standard analgesia (SoC) in adult patients admitted to the Emergency Department with moderate to severe pain associated with trauma - Pen ASAP

MUNDIPHARMA0 个研究点目标入组 360 人开始时间: 2017年12月5日最近更新: 2019年12月10日

试验速览

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•1.Men and women aged 18 or older
•2.Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
•3.Patients admitted to the emergency department due to a trauma
•4.Patients having a pain score = 4 measured using a numerical scale (NS) at the time of admission to emergency departments
•5.Patients having a pain score = 40 measured using the VAS at the time of randomisation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 360
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
•2.Impaired consciousness regardless of the cause, including head trauma or drug or alcohol consumption;
•3.Acute medicinal or alcohol intoxication, according to the investigator;
•4.Known pregnancy or lactation;
•5.Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
•6.Treatment with nitrous oxide within 5 hours before presentation at the emergency department;
•7.Use of analgesics for chronic pain;
•8.Prior use of Penthrox®;
•9.Use of an investigational product one month before presentation at the emergency department;
•10.Hypersensitivity to Penthrox® or any other fluoridated anesthetic;
•11.Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;
•12.Clinical evidence of respiratory depression;
•13.Clinical evidence of cardiovascular instability;
•14.Clinical renal or hepatic damage, according to the investigator, pre-existing or known;
•15.Presence of any other clinical condition that can, according to the investigator’s opinion, have an impact on the patient's ability to participate in the study or the results of the study.

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