34 adult (\>18 years) cancer pain outpatients with Opioid base therapy because of pain and breakthrough pain or extreme pain on movement will be included in this prospective, randomized, double-blind crossover study. Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray nasal. Primary endpoint is time to onset of action of intranasal ketamine compared with morphine drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using the spray or morphine or the combination of ketamine spray and morphine drops.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Pain Relief Unit and Anaesthesiology, University Hospital Basel
Basel, Switzerland
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 5 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 10 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 15 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 20 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 45 minutes
Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops
Time frame: after 5, 10, 15, 20, 45 minutes
Total amount of delivered applications of ketamine or morphine in each study arm
Time frame: 3 weeks
Total amount of fixed and reserve opioid doses increase in each study arm
Time frame: 3 weeks
Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa
Time frame: 3 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.