Nasal spray ketamine/dexmedetomidine for pain relief
Combined dexmedetomidine/ketamine nasal spray for analgesia: a pilot feasibility and efficacy trial in healthy volunteers
Monash Medical Centre
30 participants
Mar 2, 2020
Interventional
Conditions
Summary
Studies have consistently shown that ketamine and dexmedetomidine infusions on their own provide good and safe analgesia, decrease opioid requirements and can increase the pain-free period during the postoperative recovery. A combination of dexmedetomidine and ketamine may prevent adverse events associated with Ketamine use such as tachycardia, hypertension, salivation, as well as reduce anxiety from ketamine, whereas ketamine may prevent the bradycardia and hypotension, which has been reported with dexmedetomidine. What is more, IN is an attractive needle-free sedative option where IV access is unnecessary or may be deferred until sedation is achieved. Both ketamine and dexmedetomidine are efficacious and well tolerated when provided as an IN preparation. To our knowledge, however, very few studies have examined a combined formulation. This study will therefore seek evaluate the sedative, anxiolytic, and analgesic effects of combined dexmedetomidine and ketamine when administered via the nasal route in healthy adults.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Over a single 6 hour session, participants will be provided a combined dexmedetomidine + ketamine nasal solution, delivered as a titratable dose. Ketadex® is a 125mg/mL Ketamine and 250mcg/mL dexmedetomidine nasal solution that is administered in a proprietary nasal delivery device to administer up to 8 sprays of 12.5mg ketamine and 25mcg dexmedetomidine per 0.1ml spray. Each mL contains 144.175mg of ketamine hydrochloride equivalent to 125mg of ketamine, 295 mcg of dexmedetomidine hydrochloride equivalent to 250 mcg (0.25mg) of dexmedetomidine, 1.05mg of sodium citrate dihydrate and 0.15 mg of edetate disodium dihydrate in water. The dosing conditions are as follows: 1. Low dose: 25µg dexmedetomidine + 12.5mg ketamine (1 intranasal spray) OR 2. Medium dose: 100µg dexmedetomidine + 50mg ketamine (4 intranasal sprays performed by 1 X 0.1ml in each nostril initially followed by 1 X 0.1ml in each nostril one minute later) OR 3. High dose: 200µg dexmedetomidine + 100mg ketamine [8 intranasal sprays, performed by 1 X 0.1ml in each nostril, followed by 1 X 0.1ml in each nostril one minute later (4 intranasal sprays). Repeated one minute later with 1 X 0.1ml in each nostril, followed by 1 X 0.1ml in each nostril one minute later (4 intranasal sprays)].
Locations(1)
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ACTRN12620000117910