TerminatedPhase 1

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

Stopped: Recruitment issues

United States5 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Incidence of Adverse Events

Timeframe: up to 72 hours post-surgery or until discharge

Trial details

NCT IDNCT02341963

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Acute Pain Management trials