NCT03362073

Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients

A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients With Refractory Cancer Pain

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Ketamine, N-methyl-D-aspartate (NMDA) receptor blocker, in refractory cancer pain based on prior studies. * We cannot yet confirm the role of Ketamine comparing the benefit and risk due to incompatible results of prior studies. Additionally, most of prior studies were studied in heterogenous groups, which are from beginning of palliative chemotherapy to terminal status, so role of ketamine was not assessed in homogeneous terminally ill cancer patients. And they has used mostly 'bolus intravenous infusion' or 'continuous subcutaneous infusion (CSCI)', relatively rare in continuous intravenous infusion (CIVI). * The bolus intravenous method is convenient but is concerned with leading to relatively severe adverse events due to poor general condition of terminally ill cancer patients, the CSCI method is not recommended because of adverse events (AEs) such as skin irritation. On the contrary, the CIVI method using gradual increasing ketamine minimizes AEs and is free of skin irritation. Most of hospitalized terminally ill cancer patients has proper IV access using intravascular devices (chemoport or PICC). So, CIVI method is suitable to hospitalized terminally ill cancer patients. * This study assess the efficacy and safety of 5-days CIVI gradual dose titration of Ketamine in terminally ill cancer patients with refractory cancer pain.

Conditions

• Ketamine
• Refractory Cancer Pain

Interventions

Type	Name	Description
DRUG	Ketamine	Application of ketamine using continuous intravenous infusion method during 5 days * Ketamine 100mg/2ml + 5% Dextrose water or Normal saline 98 ml mixed fluid * Dose schedule: 0.05mg/kg/hr -\> 0.10mg/kg/hr -\> … -\> 0.5mg/kg/hr (increase dose at a rate of 0.05mg/kg/hr every 8 hours)

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-12-05
• Last updated: 2021-09-28

Locations

1 site across 1 country: South Korea