Comparing two different concentrations of Intranasal Fentanyl in adults presenting to Frankston Emergency Department with moderate to severe pain.

Recruiting

• Conditions: moderate to severe pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12615000872538
• Lead Sponsor: A/Prof Pamela Rosengarten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Visual Analog Scale (VAS) pain score from pre-administration (T0) to 30 minutes post-administration (T30) in the Standard Intranasal Fentanyl (SINF) and Concentrated Intranasal Fentanyl (CINF) groups, and the difference in the means between the two groups. Composite outcome. Assessed from the patient scored VAS recorded on the data collection form.[Pain score (VAS) at 30 minutes post analgesia.]