Status:
UNKNOWN
Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Ketamine
Refractory Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To establish the role of ketamine in hospitalized terminally ill cancer patients with refractory cancer pain, using continuous intravenous infusion of ketamine
Detailed Description
* There are approximately 20 percent patients of refractory cancer pain, which is troubled with uncontrolled pain though treatment including opioids. * Ketamine has been showed the performance of Keta...
Eligibility Criteria
Inclusion
- Among patients with histologically or cytologically confirmed malignancy, patients with expected survival time of several months or less due to a progressive disease without additional anticancer treatment.
- Patients with refractory cancer pain, which cases of requesting 4 or more breakthrough analgesics or increase of baseline analgesics (average pain score ≥ 4 or Personalized pain goal) in spite of 120 mg/day or more of intravenous Morphine Equivalent Daily Dose
- Hospitalized patients with intravascular access during at least 5 days
- Age 18 or older
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment
Exclusion
- Patients who were treated with ketamine for pain control within 6 months
- Patients who have been treated with radiotherapy within 4 weeks or plan to intervention for pain control during study period
- Cancer pain cannot be excluded the Opioid induced hyperalgesia
- Concomitant severe medical, surgical, or disease or problems which were contraindicated to application of Ketamine or have possibilities of unexpected medical problems caused be the Ketamine
- confirmed or assumed central nervous system lesion which lead to increased intracranial pressure
- Arrhythmia (supra-ventricular tachycardia, ventricular arrhythmia (frequent premature ventricular contraction, bigeminy, Ventricular tachycardia)
- history of hemorrhagic stroke or seizure within 3 months
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03362073
Start Date
June 1 2018
End Date
December 31 2021
Last Update
September 28 2021
Active Locations (1)
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1
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612