Intranasal Ketamine and Ketamine Hydrochloride in Reducing Uncontrolled Pain in Patients with Cancer

Inclusion Criteria

• Patients with uncontrolled pain related to cancer or cancer treatment; uncontrolled pain will be defined as * Pain which persists for more than 7 days and is rated >= 4 on NPRS * Use of breakthrough medication more than 4 times in 24 hours or being treated with oral morphine equivalent of 50 mg/d or more
• Patients who are able to follow-up in person during the trial
• Patient on stable analgesic regimen for > 7 days without escalation during study period with rescue or immediate release medication every 3 hours or longer
• Patients who are willing and able to maintain a daily pain diary
• Patients who are able to understand written and verbal English
• Patient weight >= 50 kg

Exclusion Criteria

• Transportation issues interfering with return study visits
• Patients with high disposition of laryngospasm or apnea
• Presence of severe cardiac disease
• Presence of conditions where significant elevations in blood pressure would be a serious hazard
• Stage 2 hypertension or greater (systolic blood pressure > 160 and/or diastolic blood pressure > 100)
• Baseline tachycardia, heart rate (HR) > 100
• History of seizures, elevated intracranial pressure (ICP) or cerebrospinal fluid (CSF) obstructive states (e.g. severe head injury, central congenital or mass lesions)
• Conditions that may increase intraocular pressure (e.g. glaucoma, acute globe injury)
• History of uncontrolled depression or other psychiatric comorbidity with psychosis
• History of liver disease
• History of interstitial cystitis
• History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis
• Patients with lesions to the nasal mucosa
• Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective; highly effective contraception methods include combination of any two of the following: * Use of oral, injected or implanted hormonal methods of contraception or; * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; * Total abstinence; * Male/female sterilization
• Illicit substance abuse within the past 6 months
• Documented history of medication abuse/misuse (e.g. unsanctioned dose escalation, broken opioid agreement etc.)
• Clinical requirement for medications that are concurrent inducers or strong inhibitors of CYP3A4; CYP3A4 substrates are allowed
• Porphyria (possibility of triggering a porphyric reaction)
• Severe active anemia (a hemoglobin < 8 documented by labs drawn within 3 months of first study treatment)
• History of difficult intravenous access
• Intractable vomiting