A prospective randomized study comparing the efficacy of two different concentrations of Intranasal Fentanyl: the standard formulation (50mcg/mL) and the concentrated formulation (300mcg/mL) in adults presenting to Frankston Emergency Department (ED) with moderate to severe pain.

A/Prof Pamela Rosengarten0 个研究点目标入组 110 人开始时间: 2015年8月21日最近更新: 2020年1月13日

试验速览

暂无简介。

•1. Age 18 years to 75 years of age
•2. Self-report pain severity as being 6 or more on the standard 10 point verbal rating scale (0 is none, 10 is worst pain imaginable)
•3. Medical recommendation for parenteral analgesia (treating doctor’s discretion)
•4. Pain from any cause other than the 3 specific exclusions (see below)

•1. Known allergy or previous adverse reaction to fentanyl
•2. Patients over 75 years of age
•3. Use of oral, intranasal, transdermal 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]
•4. MAO Inhibitor antidepressant use within last 14 days
•5. Myasthenia gravis
•6. Haemodynamic instability (eg HR over 120/min or BP under 90 mmHg) with the need for time critical interventions of any type
•7. 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

发起方

A/Prof Pamela Rosengarten