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

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ClinicalTrials.gov Identifier: NCT02341963
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Pain Management Analgesic, Nonopioid Amputation of Lower Extremity, All Causes Drug: Oral Ketamine Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Oral Ketamine
Subjects will receive Oral Ketamine (1.0 mg/kg) ) presurgery and 3 days postsurgery (including surgery day).
Drug: Oral Ketamine
Oral ketamine (Ketamine HCL injection, 100 mg/ml, USP, Hospira)




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: up to 72 hours post-surgery or until discharge ]
    Incidence of adverse events with oral ketamine


Secondary Outcome Measures :
  1. Acute Postoperative Pain (NRS (numerical rating scale, 0=no pain, 10=worst imaginable pain) score) [ Time Frame: 0 to 72 hours post-surgery ]
    Patient NRS (numerical rating scale, 0=no pain, 10=worst imaginable pain) score of postoperative pain adjacent to body part that was amputated, at 48 hours post-surgery (average pain over previous 4 h).

  2. Chronic Postoperative Pain (SF-MPQ scale for phantom limb and stump pain;Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: 1, 3, 6 months post-surgery ]
    Assessment of stump pain and phantom limb pain using; SF-MPQ scale for phantom limb and stump pain;Defense and Veterans Pain Rating Scale (DVPRS); S-LANSS neuropathic pain scale, RAND 36 Item Health Survey (SF-36) quality of life scale

  3. Pharmacokinetics of Plasma Ketamine and Norketamine Levels (ng/mL) [ Time Frame: Post-operative day 1 and 1 and hours after the first morning study drug dose ]
    The purpose is to be able to relate plasma drug levels to adverse events and side effects.

  4. Liver Function Test [ Time Frame: 1 month after surgery and every month until liver function levels return to normal ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341963


Contacts
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Contact: Sherry J Robison, MBA 312-942-2985 Sherry_J_Robison@rush.edu
Contact: Mario Moric 312-942-2806 mario_moric@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Asokumar Buvanendran, M.D.         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Asokumar Buvanendran, M.D. Professor Anesthesiology, Rush Unviersity Medical Center

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Responsible Party: Asokumar Buvanendran, Professor, Department of Anesthesiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02341963     History of Changes
Other Study ID Numbers: ORA#: 14071504
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Ketamine
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action