A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
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|ClinicalTrials.gov Identifier: NCT02341963|
Recruitment Status : Terminated (Recruitment issues)
First Posted : January 19, 2015
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Management Analgesic, Nonopioid Amputation of Lower Extremity, All Causes||Drug: Oral Ketamine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-Label Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2020|
|Actual Study Completion Date :||January 2021|
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)
- Incidence of Adverse Events [ Time Frame: up to 72 hours post-surgery or until discharge ]Incidence of adverse events with oral ketamine
- 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).
- 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
- 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.
- Liver Function Test [ Time Frame: 1 month after surgery and every month until liver function levels return to normal ]
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
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Asokumar Buvanendran, M.D.||Professor Anesthesiology, Rush Unviersity Medical Center|