Efficacy of intranasal fentanyl for the treatment of moderate to severe pain in adult patients in the emergency department
- Conditions
- Moderate to severe pain in patients over 18yo presenting to Frankston ED. Pain can be from any cause except as specified by the exclusion criteria. Definition of moderate to severe pain is 6 out of 10 or more (self rated by patient) on a visual analog score, where 0 is no pain and 10 is the worst pain imaginable.Anaesthesiology - Pain management
- Registration Number
- ACTRN12613000652774
- Lead Sponsor
- Peninsula Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 150
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Visual Analog Scale pain score (VAS) from pre-administration (T0) to 30 minutes post-administration (T30)[T30]
- Secondary Outcome Measures
Name Time Method