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Clinical Trials/ACTRN12615000872538
ACTRN12615000872538
Recruiting
Not Applicable

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 sites110 target enrollmentAugust 21, 2015
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
A/Prof Pamela Rosengarten
Enrollment
110
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 21, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
A/Prof Pamela Rosengarten

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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