A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
Stopped early · Phase 1
Conditions studied: Acute Pain Management, Analgesic, Nonopioid, Amputation of Lower Extremity, All Causes
In brief
The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain after amputation surgery. The objective of the proposed research is to conclusively determine if oral ketamine is a safe alternative analgesic to opioid for acute pain in subjects undergoing elective amputation of the lower extremity. All participants will receive oral ketamine.
Key facts
- Study ID
- NCT02341963
- Run by
- Rush University Medical Center
- People needed
- 5
- Starts
- 2015-01-01
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2021-03-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults of at least 18 years of age, but not older than 80 years
- 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 may not qualify if…
- Pregnancy
- Increased intracranial pressure or intraocular pressure
- Allergy to ketamine
- Morbid obesity (BMI > 40 kg/m2)
- Significant comorbidity (ASA physical status classification > 3)
- Inability to communicate with the investigators
- Any history of known or suspected drug or alcohol abuse
- History of impaired liver function
- Significant history of hallucinations, delusions or other psychiatric medical condition the investigator feels will prevent assessment of adverse events of study drug.
- Significant psychiatric history; a diagnosis of schizophrenia, bipolar disorder, or severe depression.
- Exposure to cytochrome P450 3A4 inhibitors or inducers (including grapefruit products) within 2 weeks before enrollment; the inability to avoid these products during ketamine administration.
- Poorly-controlled hypertension
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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