Clinical trial NCT02591017: Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
Official title: Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer: Breakthrough Pain
Cancer: Extreme Pain on Movement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Cancer pain in outpatients with:
* Opioid based therapy due to pain
* Breakthrough pain or
* Extreme pain on movement
* Age \>= 18 years

Exclusion Criteria:

* Patients unable to give written informed consent
* Patients unable to understand how to handle and document the use of the study medication
* Known drug allergies or intolerance to ketamine
* Known drug allergies or intolerance to morphine
* Known allergy to crustacea or chitosan
* Patients using snuff at a regular basis
* Recreational drug addiction or abuse
* Serious intranasal or epipharyngeal Problems (Septum wall defects, cancer)
* Mental/psychiatric disorder
* Patients with renal failure (clearance \< 30 ml/min)
* Pregnancy and breast feeding mothers
* Patients not understanding German
* Patient having arterial hypertonia with measured values \> 180/95

Primary outcomes:
measure: Time to onset of action of intranasal ketamine compared with morphine drops
timeFrame: 5 minutes
measure: Time to onset of action of intranasal ketamine compared with morphine drops
timeFrame: 10 minutes
measure: Time to onset of action of intranasal ketamine compared with morphine drops
timeFrame: 15 minutes
measure: Time to onset of action of intranasal ketamine compared with morphine drops
timeFrame: 20 minutes
measure: Time to onset of action of intranasal ketamine compared with morphine drops
timeFrame: 45 minutes
Secondary outcomes:
measure: Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops
timeFrame: after 5, 10, 15, 20, 45 minutes
measure: Total amount of delivered applications of ketamine or morphine in each study arm
timeFrame: 3 weeks
measure: Total amount of fixed and reserve opioid doses increase in each study arm
timeFrame: 3 weeks
measure: Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Pain Relief Unit and Anaesthesiology, University Hospital Basel
Study officials:
affiliation: Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland
name: Wilhelm Ruppen, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: