Safety of intranasal ketamine for reducing uncontrolled cancer-related pain: Protocol of a phase i/II clinical trial

摘要: Background: Approximately 12 million Americans are affected with cancer. Of these, 53% experience pain at all stages of Pain may remain uncontrolled despite high-dose opioid therapy, and opioids have many well-documented harmful side effects. Intranasal ketamine has been shown to be effective in controlling breakthrough noncancer a double-blind randomized control trial (DBRCT) by Carr et al 2003 as well help depression DBRCT Lapidus 2014. We seek obtain preliminary data on the safety, feasibility, utility this novel technique for treatment cancer pain. Objective: This study aimed via clinical addressing pharmacokinetics, pharmacodynamics intranasal ketamine. These initial findings will applied subsequent determine effectiveness associated toxicities larger sample patients address compelling need identify new, successful management therapies Methods: is an institutional review board– investigational new drug–approved, prospective phase I/II investigate safety use related or treatment. Informed consent obtained prior procedures. All assigned same arm. After patient selection inclusion/exclusion criteria, seen over 5 visits, each visit conducted 2-7 days apart. Patients administered visits 1-4 monitored 240 minutes continuous pulse oximetry regular blood pressure checks. Blood samples patient-reported outcomes collected set time points baseline after drug delivery. receive 10 mg 1, intravenous 2, 30 3, 50 4. On 5, addition drawn. Results: As March 2019, enrollment progress, total 7 subjects completed study. Enrollment expected April 2019. Final analysis commence soon after, results submitted publication Conclusions: If can utilized patients, it could provide superior analgesia better quality life, without risk significant respiratory constipation medications. important step toward testing nonopioid medication potential maintenance outpatient therapy. Trial Registration: ClinicalTrials.gov NCT03146806; https://clinicaltrials.gov/ct2/show/NCT03146806. International Registered Report Identifier (IRRID): DERR1-10.2196/12125