Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients (ONKEMI)

University Hospital Basel

Status and phase

Terminated

Phase 3

Conditions

Cancer: Extreme Pain on Movement

Cancer: Breakthrough Pain

Treatments

Drug: Placebo

Drug: Morphine

Drug: Chitosan

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02591017

EKNZ 2014-249

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

11 participants in 3 patient groups

morphine drops solo and placebo spray

Other group

Description:

morphine 2% drops 1. daily fixed dose of morphine equivalents \< 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards 2. daily fixed dose of morphine equivalents =/\> 100 mg, 15% of the fixed daily dose in morphine drops every hour in reserve due to international standards

Treatment:

Drug: Morphine

Drug: Placebo

ketamine/chitosan spray nasal and placebo drops

Other group

Description:

5 mg ketamine all 5 minutes, maximal 4 times an hour

Treatment:

Drug: Ketamine

Drug: Chitosan

Drug: Placebo

morphine drops and ketamine/chitosan spray nasal