Not provided
Not provided
Not provided
Not provided
insufficient enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morphine drops solo and placebo spray | Other | morphine 2% drops
|
|
| ketamine/chitosan spray nasal and placebo drops | Other | 5 mg ketamine all 5 minutes, maximal 4 times an hour |
|
| morphine drops and ketamine/chitosan spray nasal | Other | see above |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug |
| ||
| Ketamine |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of action of intranasal ketamine compared with morphine drops | 5 minutes | |
| Time to onset of action of intranasal ketamine compared with morphine drops | 10 minutes | |
| Time to onset of action of intranasal ketamine compared with morphine drops | 15 minutes | |
| Time to onset of action of intranasal ketamine compared with morphine drops | 20 minutes | |
| Time to onset of action of intranasal ketamine compared with morphine drops | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops | after 5, 10, 15, 20, 45 minutes | |
| Total amount of delivered applications of ketamine or morphine in each study arm | 3 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wilhelm Ruppen, PD Dr. med. | Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Relief Unit and Anaesthesiology, University Hospital Basel | Basel | 4031 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D007649 | Ketamine |
| D048271 | Chitosan |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Placebo | Drug |
|
| Chitosan | Drug |
|
| Total amount of fixed and reserve opioid doses increase in each study arm | 3 weeks |
| Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa | 3 weeks |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002686 | Chitin |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |