None listed
Conditions
Brief summary
Pain is a common presenting symptom in the emergency department patient population with opioids being the cornerstone of treatment for moderate to severe pain. Fentanyl is a safe and effective opioid drug which is commonly used in adults and children for this indication. Rapid analgesia is usually effected in emergency patients by administering an opioid via the intravenous route 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. The intranasal (IN) route has increasingly been viewed as an alternative route for drug administration. It is 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. The effective treatment of acute pain in children with intranasal opioids such as fentanyl is well documented. There is also evidence in adult acute and chronic pain settings that fentanyl in analgesic doses by the intranasal route provides effective analgesia. A significant limitation of using IN fentanyl in the adult population in the hospital setting is the inability to access the concentrated formulation (300mcg/ml). This preparation is more expensive than the widely available standard formulation (50mcg/ml) fentanyl and so is not widely accessible for use. Effective IN analgesia in adults requires the more concentrated formulation of fentanyl due nasal absorption considerations. This is a non-randomised single group study of IN fentanyl in 150 adult patients with moderate to severe pain from all causes. Patients presenting with pain greater or equal to 6 out of 10 will be given a dose of concentrated (300mcg/ml) IN fentanyl. Pain scores will be taken at regular intervals over 60 minutes. If there is no response by 15 minutes a second dose of fentanyl will be given. If no appreciable pain relief occurs by 30 minutes, standard IV opioid analgesia will be given. The results of this study will provide information on the effectiveness of fentanyl in the treatment of moderate to severe pain in adult ED patients and will allow us to determine future sample sizes for prospective comparative studies of fentanyl to other pain relievers used in the ED.
Interventions
fentanyl citrate, concentrated solution of 300mcg/ml.
Dosage will depend on bodyweight. Initially 1.4mcg/kg will be administered intranasally, using an atomiser device attached to a syringe. A subsequent 0.7mcg/kg will be administered 15 minutes after the first dose if the patient is requesting further analgesia.
If at any point the patient requests further analgesia, they will receive standard emergency treatment such as intravenous morphine.
Study drug will be administered at the time of e
fentanyl citrate, concentrated solution of 300mcg/ml. Dosage will depend on bodyweight. Initially 1.4mcg/kg will be administered intranasally, using an atomiser device attached to a syringe. A subsequent 0.7mcg/kg will be administered 15 minutes after the first dose if the patient is requesting further analgesia. If at any point the patient requests further analgesia, they will receive standard emergency treatment such as intravenous morphine. Study drug will be administered at the time of enrolement, and at 15 minutes if requested by patient. Follow up time points will occur at 30 minutes and 60 minutes. The total duration of the study will be 60 minutes.
Sponsors
Peninsula Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed