Overview

A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery

Status:
Terminated

Trial end date:
2021-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rush University Medical Center

Treatments:

Ketamine

Criteria

Inclusion Criteria:

1. Adults of at least 18 years of age, but not older than 80 years

2. 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.

Exclusion Criteria:

1. Pregnancy

2. Increased intracranial pressure or intraocular pressure

3. Allergy to ketamine

4. Morbid obesity (BMI > 40 kg/m2)

5. Significant comorbidity (ASA physical status classification > 3)

6. Inability to communicate with the investigators

7. Any history of known or suspected drug or alcohol abuse

8. History of impaired liver function

9. Significant history of hallucinations, delusions or other psychiatric medical
condition the investigator feels will prevent assessment of adverse events of study
drug.

10. Significant psychiatric history; a diagnosis of schizophrenia, bipolar disorder, or
severe depression.

11. 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.

12. Poorly-controlled hypertension