NCT02341963

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

5.9 years

First QC Date

January 12, 2015

Last Update Submit

February 24, 2021

Conditions

Acute Pain ManagementAnalgesic, NonopioidAmputation of Lower Extremity, All Causes

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Incidence of adverse events with oral ketamine

    up to 72 hours post-surgery or until discharge

Secondary Outcomes (4)

  • Acute Postoperative Pain (NRS (numerical rating scale, 0=no pain, 10=worst imaginable pain) score)

    0 to 72 hours post-surgery

  • Chronic Postoperative Pain (SF-MPQ scale for phantom limb and stump pain;Defense and Veterans Pain Rating Scale (DVPRS)

    1, 3, 6 months post-surgery

  • Pharmacokinetics of Plasma Ketamine and Norketamine Levels (ng/mL)

    Post-operative day 1 and 1 and hours after the first morning study drug dose

  • Liver Function Test

    1 month after surgery and every month until liver function levels return to normal

Study Arms (1)

Oral Ketamine

EXPERIMENTAL

Subjects will receive Oral Ketamine (1.0 mg/kg) ) presurgery and 3 days postsurgery (including surgery day).

Drug: Oral Ketamine

Interventions

Oral KetamineDRUG

Oral ketamine (Ketamine HCL injection, 100 mg/ml, USP, Hospira)

Oral Ketamine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Buvanendran A, Kroin JS, Rajagopal A, Robison SJ, Moric M, Tuman KJ. Oral Ketamine for Acute Pain Management After Amputation Surgery. Pain Med. 2018 Jun 1;19(6):1265-1270. doi: 10.1093/pm/pnx229.

    PMID: 29025089RESULT

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Asokumar Buvanendran, M.D.

    Professor Anesthesiology, Rush Unviersity Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Anesthesiology

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

US(1)