NTNU Intranasal Naloxone Trial - a Double Blinded, Double Dummy, Randomized Controlled Trial of Intranasal Naloxone for Pre-hospital Use
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Proportion of patients with return of spontaneous respiration (above or equal to 10 breaths per minute) within 10 minutes of naloxone administration in pre-hospital opioid overdose
研究概览
简要总结
This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The whole study team, including the statistician, will be blinded until after database lock and the primary analysis are done. The allocation list will be stored by by the Hospital Pharmacy Trondheim. There will not be automatic unblinding of SAEs. Study personnel do not have any access to the allocation list. An emergency option for individual unblinding is available to medical monitor in case of SAE/ SUSAR Study workers are blinded to the different preparations. This is carefully performed by covering the vials with neutral and opaque labels for "study drug". The risk of for unintentional unblinding is very small. The procedure for securing credible blinding is described in the study protocol and approved by the Norwegian Medicines Agency.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected opioid overdose clinically diagnosed by emergency medical service (EMS) based on the following criteria
- •Reduced (below and equal to 8 breaths per minute) or absent spontaneous respiration
- •Glasgow Coma Scale (GCS) below 12
- •Palpable carotid or radial arterial pulse
排除标准
- •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 or other health care workers in the pre- hospital setting
- •Suspected or visibly pregnant participant
- •Has received naloxone by any route in the current overdose
- •in prison or custody by police
- •EMS staff without training as study workers
- •No study drug available
- •Study drug frozen as indicated by Freeze Watch in kit or past its expiry date
- •Deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for EMS
研究组 & 干预措施
Naloxone, intranasal
干预措施: Naloxone, intranasal (Drug)
Naloxone, intramuscular
干预措施: Naloxone, intramuscular (Drug)
placebo, intranasal
干预措施: placebo, intranasal (Drug)
placebo, intramuscular
干预措施: placebo, intramuscular (Drug)
结局指标
主要结局
Proportion of patients with return of spontaneous respiration (above or equal to 10 breaths per minute) within 10 minutes of naloxone administration in pre-hospital opioid overdose
时间窗: 40 minutes
次要结局
- Changes in Glasgow Coma Scale (GCS) in patients treated with study medicine for opioid overdose(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Changes in oxygen saturation (SaO2) in patients treated with study medicine for opioid overdose(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Overdose complications(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Time from administration of naloxone to respiration above or equal to 10 breaths per minute(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Opioid withdrawal reaction to naloxone reversal(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Suitability of spray device in pre-hospital setting(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Adverse reactions to naloxone formulation(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Need for rescue naloxone, dose and route of administration during study visit(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- Recurrence of opioid overdose/ need for further pre-hospital naloxone within 12 hours of inclusion(12 hours)
- reasons not to give rescue naloxone to non-responders(The time participants are in the care of ambulance personnel, estimated 40 minutes)
- follow-up after care(The time participants are in the care of ambulance personnel, estimated 40 minutes)