None listed
Conditions
Brief summary
Pain is a common presenting symptom in the emergency department. For moderate to severe pain, standard treatment is an intravenously administered opioid. But this can be associated with pain, inconvenience and delay as it requires the insertion of an intravenous cannula. The intranasal route of administration of opioids offers an attractive alternative as it is non invasive and does not require intravenous access. It also provides an alternative where intravenous access is difficult or not required and where nausea and vomiting prevent oral drug administration. In a number of patients intravenous access may then be completely avoided. IN Fentanyl is already commonly used in the paediatric population where more invasive methods of drug delivery (intravenous or intramuscular) may result in significant discomfort, anxiety and increased stress during a hospital visit. For adults who require larger doses of fentanyl, there is a concentrated version available (CINF), hower it is not generally used in emergency departments due to its cost. (An ampoule of concentrated INF (300mcg/mL) is $28.14 and the standard INF (50mcg/mL) is 56 cents. We have recently completed a pilot study of concentrated INF in 41 adult patients presenting to Frankston ED with moderate to severe pain. (CINF was specifically purchased for this study funded by a grant by the PHREC). Our results showed that CINF was a safe, well tolerated and efficacious in this patient population. The standard INF which is inexpensive and widely available has not been studied in adults in the acute setting as has been done in children. We are proposing a randomised equivalence study of CINF versus the SINF, which is readily available in the ED at a fraction of the cost. If equivalence is proven then standard concentration can be recommended for IN use in adults. A similar study was performed by Borland et al. in children and found that the two formulations of IN fentanyl were equally effective at reducing pain scores. Hypothesis: standard intranasal fentanyl (SINF) and concentrated intranasal fentanyl (CINF) are equally effective and safe in reducing moderate to strong pain in adult patients in the ED.
Interventions
Intranasal Fentanyl Standard Formulation (50mcg/mL)
Single Dose, administered by treating doctor immediately on arrival (patients with moderate to severe pain with pain score greater than or equal to 6 ). Administration of the medication will be witnessed by a nurse as well.
Sponsors
A/Prof Pamela Rosengarten
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed