Clinical Trial TitleRandomized, placebo controlled phase 1 clinical trial of oral ketamine (pilot) for acute pain management after amputation surgery.
Clinical Trial Protocol Description:
The purpose of this study is to determine whether oral ketamine, given for 3 days, controls pain management for amputation patients.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age, but not older than 80 years.
- Are due to undergo elective major amputation of the lower extremity (above the knee amputation [AKA], below the knee amputation [BKA], total knee amputation [TKA], transmetatarsal amputation [TMA], toe amputation) from all causes.
You will be excluded from the study if any of the following criteria apply to you:
- Are pregnant.
- Have increased intracranial pressure or intraocular pressure. Ketamine can increase these pressures.
- Have an allergy to ketamine.
- Are morbidly obesity (BMI > 40 kg/m2).
- Have significant comorbidity (ASA physical status classification > 3).
- Are not able to communicate with the investigators.
- Have any history of known or suspected drug or alcohol abuse.
- Have a history of impaired liver function.
- Have a significant history of hallucinations, delusions or other psychiatric medical condition.
- Have a significant psychiatric history, a diagnosis of schizophrenia, bipolar disorder, or severe depression.
- Have had exposure to cytochrome P450 3A4 inhibitors or inducers (including grapefruit products) within 2 weeks before enrollment or have the inability to avoid these products during ketamine administration.
- Have poorly controlled hypertension.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.