ACTRN12613000652774尚未招募不适用
Efficacy of intranasal fentanyl for the treatment of moderate to severe pain in adult patients in the emergency department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •Age greater or equal to 18 years
- •Self-report pain severity as being greater than or equal to 6 on the standard 11-point verbal rating scale, where 0 is no pain and 10 is the worst pain imaginable
- •Medical recommendation for parenteral analgesia (attending doctor’s discretion)
- •Pain from any cause other than the specific exclusion criteria (see below)
排除标准
- •Known allergy or previous adverse reaction to fentanyl
- •Use of oral, intranasal or parenteral narcotic analgesia in previous 4 hours (either pre-hospital or in the emergency department) [NB. Pre-hospital use of short-acting inhaled methoxyfluorane alone or non-narcotic analgesics do not constitute an exclusion]
- •MAO Inhibitor antidepressant use within last 14 days
- •Haemodynamic instability (eg HR > 120/min or BP < 90 mmHg) with the need for time critical interventions of any type
- •Suspicion of any of the following medical conditions:
- •myocardial ischaemia (concern re transient hypotension from fentanyl)
- •suspected subarachnoid haemorrhage (concern re transient hypotension from fentanyl)
- •migraine (specific proven therapy)
- •Relative contraindication to, or anticipated difficulty with nasal administration of medication that may prevent adequate administration or absorption of intranasal medication (eg aberrant nasal anatomy, acute or chronic nasal problems or nasal trauma).
- •Presence of acute cognitive impairment (any underlying cause)
- •Schizophrenia or related psychiatric conditions (even if currently well controlled)
- •History of recreational substance abuse
- •Inability to understand study explanation or procedures, or to provide informed consent
- •Pregnancy, breast feeding
研究者
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