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

Ketamine

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.

Intervention / Treatment

  • Morphine (DRUG)
    N/A
  • Ketamine (DRUG)
    N/A
  • Placebo (DRUG)
    N/A
  • Chitosan (DRUG)
    N/A

Condition or Disease

  • Cancer: Breakthrough Pain
  • Cancer: Extreme Pain on Movement

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 11 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Feb 01, 2015
    Primary Completion: Jul 01, 2017 ACTUAL
    Completion Date: Jul 06, 2017 ACTUAL
    Study First Posted: Oct 29, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 08, 2018

    Sponsors / Collaborators

    Lead Sponsor: University Hospital, Basel, Switzerland
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Basel, Basel-Stadt, Switzerland

    Participant Groups

    • 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

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

    • see above

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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
    • 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
    Secondary Outcomes
    • 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

    More Details

    NCT Number: NCT02591017
    Acronym: ONKEMI
    Other IDs: EKNZ 2014-249
    Study URL: https://clinicaltrials.gov/study/NCT02591017
    Last updated: Sep 29, 2023