TNU Intranasal Naloxone TrialDouble blinded, double dummy, randomised controlled trial of intranasal naloxone for pre hospital use - NTNU Intranasal Naloxone Trial

orwegian University of Science and Technology (NTNU)0 个研究点目标入组 286 人开始时间: 2016年11月2日最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•-Suspected opioid overdose clinically diagnosed by Emergency Medical Staff (EMS) based on the following criteria
•1.Reduced (below or equal to 8 breaths per minute) or absent spontaneous respiration
•3.Glasgow Coma Scale (GCS) below 12
•-Palpable carotid or radial arterial pulse
•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 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Cardiac arrest
•-Failure to assist ventilation using mask- bag technique
•-Facial trauma or epistaxis or visible nasal blockage
•-Iatrogenic opioid overdose when opioid is administered in- hospital, or by EMS in the pre hospital setting
•-Suspected participant below 18 years of age
•-Participant visibly pregnant
•-Participant that have received nasal naloxone by non- EMS staff in the current overdose
•-EMS staff without adequate training as study workers
•-No study drug available
•-Deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for EMS.

发起方

orwegian University of Science and Technology (NTNU)