At a glance
ClinicalIndex Comparison Record- ✓Uncontrolled cancer pain defined as pain ≥4/10 persisting >7 days, OR breakthrough medication >4 times/24h, OR on morphine equivalent ≥50 mg/day
- ✓Able to follow-up in person during the trial
- ✓On stable analgesic regimen for >7 days without escalation during study period, with rescue/immediate release medication every 3 hours or longer
- ✓Willing and able to maintain daily pain diary
- ✕History of seizures, elevated intracranial pressure, or CSF obstructive states
- ✕Severe cardiac disease or conditions where blood pressure elevation would be hazardous
- ✕Stage 2 hypertension or greater (systolic >160 and/or diastolic >100 mmHg)
- ✕Baseline tachycardia with heart rate >100 bpm
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer Related Pain
In Brief
A Phase 2 clinical trial evaluating Intranasal ketamine for Cancer and Pain. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The main purpose of this study is to determine the safety, feasibility, and utility of intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective clinical trial the researchers will investigate the use of NAS ketamine in patients with pain related to cancer or cancer treatment. The researchers plan to enroll at least 25 patients meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the study. Participants will be recruited from the supportive oncology clinic, oncology clinics, the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five days apart. During these visits participants will complete questionnaires, have blood samples drawn and will have study medication administered to them in escalating doses. For safety monitoring participants will be contacted by telephone 14 days after the last dose of medication administered.
Study Details
Timeline
Interventions
10mg of intranasal ketamine will be given to make sure that the study patients are able to tolerate a small dose of NAS ketamine. On the second visit, 10 mg of IV ketamine will be given to help establish bioavailability of NAS ketamine, with patients serving as their own controls. On the third and fourth visit, higher doses of ketamine, 30 mg and 50 mg respectively, will be given. All doses of ketamine will be administered by an anesthesia research nurse.