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

Phase 3

Terminated

• Conditions: Cancer: Breakthrough Pain; Cancer: Extreme Pain on Movement
• Interventions: Drug: Ketamine; Drug: Morphine; Drug: Placebo; Drug: Chitosan

• Registration Number: NCT02591017
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Primary Completion: 2017-07
• Study Completion: 2017-07-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ketamine/chitosan spray nasal and placebo drops	Ketamine	5 mg ketamine all 5 minutes, maximal 4 times an hour
ketamine/chitosan spray nasal and placebo drops	Placebo	5 mg ketamine all 5 minutes, maximal 4 times an hour
ketamine/chitosan spray nasal and placebo drops	Chitosan	5 mg ketamine all 5 minutes, maximal 4 times an hour
morphine drops solo and placebo spray	Placebo	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
morphine drops and ketamine/chitosan spray nasal	Ketamine	see above
morphine drops and ketamine/chitosan spray nasal	Chitosan	see above
morphine drops solo and placebo spray	Morphine	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
morphine drops and ketamine/chitosan spray nasal	Morphine	see above

Primary Outcome Measures

Name	Time	Method
Time to onset of action of intranasal ketamine compared with morphine drops	45 minutes

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Pain Relief Unit and Anaesthesiology, University Hospital Basel; 🇨🇭 Basel, Switzerland