TerminatedPhase 1ketamine

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

Sponsored by Rush University Medical Center

NCT ID
NCT02341963
Target Enrollment
5 participants
Start Date
2015-01
Est. Completion
2021-01

About This Study

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.

Conditions Studied

Acute Pain ManagementAnalgesic, NonopioidAmputation of Lower Extremity, All Causes

Interventions

  • Oral Ketamine

Eligibility

Age:18 Years - 80 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

Rush University Medical Center
Chicago, Illinois, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source