None listed
Conditions
Brief 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.
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
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)].
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
- Male/female, 21 to 45 years. - Weight 50-130kg - Full drivers licence - Free from neurological conditions, depression or psychiatric disorders. - No history of drug abuse or dependence - No known allergy to study drugs - Not currently taking medications that could affect the outcome of the study.
Exclusion criteria
- Patients unable to provide written informed consent - Body mass index (BMI) over 40 kg/m2 or weight over 130kg - Patient is pregnant or lactating - Chronic pain medication - History of psychosis - History of neurological conditions or previous or current history of psychiatric, renal, cardiac, endocrine, gastrointestinal, or bleeding disorders. - Documented complex regional pain syndrome - Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. - Patient has been previously enrolled in the NasDex trial - Individuals with any history of nasal disorders, nasal surgeries, sinus surgeries or sinus disease
Outcome results
None listed