CLINICAL TRIALS PROFILE FOR NORKETAMINE

Clinical Trials for Norketamine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00598195 ↗	Ketamine Pharmacokinetics in Children Having Heart Surgery	Completed	Arkansas Children's Hospital Research Institute	N/A	What are the pharmacokinetics of ketamine in infants and children requiring ketamine for induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass). Specific Aim 2: To describe the disposition of ketamine's primary active metabolite, norketamine,following a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB. Specific Aim 3: To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time.
NCT00618397 ↗	Pharmacokinetics of Low Dose Ketamine Infusion	Terminated	University of Texas Southwestern Medical Center	Phase 1	Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain control. Opioid tolerance, the need to increase the dose of medication to achieve the same effect,is seen in PICU children who require opioid infusions. Animals and human studies have shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the development of opioid tolerance and that deactivation of this receptor can slow the development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in inhibiting the development of opioid tolerance has not been tested in children. We aim to determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require fentanyl infusions to treat pain and discomfort . Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr. Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for discomfort or pain control will be enrolled. Patients' age three to eighteen years will be enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a validated scale that measures distress in PICU patients. The COMFORT score will be continued for the twelve hours the patient receives the ketamine to test whether the ketamine adds to the level of sedation. Blood samples during and following the ketamine infusion will be taken to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the body. To determine the effect of ketamine on tolerance it must be a ketamine dose that does not cause additional sedation. The goal of this study is to define a non-sedating dose of ketamine and define how it is used by the body. A non-sedating ketamine dose could be added to current sedation regimens allowing us to monitor the development of tolerance without the confusion of added sedation. The data obtained in this study will be used to design a study to further investigate the effect of ketamine on opioid tolerance.
NCT01207206 ↗	Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients	Unknown status	Tel-Aviv Sourasky Medical Center	N/A	In the current research the investigators would like to examine the effect of a well acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations. Usually the ketamine is given into the vein and not orally. The investigators want to give it orally to cancer patients that sufffer from severe pain to find out whether it can prove their quality of life, lower their pain and reduce the amount of opioids they receive.
NCT02016664 ↗	Plasma Concentration of Ketamine and Norketamine .	Completed	Lawson Health Research Institute	N/A	Oral ketamine is increasingly used by doctors to both reduce the amount of narcotic pain medication consumed and to improve chronic pain management in difficult cases. How much is absorbed when taken orally, as opposed to intravenously ,is unknown. Ketamine may cause sedation, and occasionally cognitive impairment. Therefore, there are safety concerns associated with its usage as an out-patient may engage in activities where cognitive impairment is dangerous,such as driving. This study is designed to measure the plasma concentrations of ketamine and its active metabolite, norketamine, in people taking low dose oral ketamine for chronic pain. The goal of the study is to verify that low dose oral ketamine produces plasma concentrations below the level associated with toxic symptoms,and thus can be safely used long-term for the treatment of chronic pain .

Clinical Trial Conditions for Norketamine

Condition Name

Condition Name
Intervention	Trials
Major Depressive Disorder	2
Excitatory Amino Acid Agents	1
Opioid-use Disorder	1
Healthy	1

Condition MeSH

Condition MeSH
Intervention	Trials
Depressive Disorder, Major	3
Depressive Disorder	3
Depression	2
Neuralgia	1

Clinical Trial Locations for Norketamine

Trials by Country

Trials by Country
Location	Trials
United States	8
Canada	1
Israel	1
Germany	1
Finland	1

Trials by US State

Trials by US State
Location	Trials
New York	2
Maryland	1
Illinois	1
North Carolina	1
California	1

Clinical Trial Progress for Norketamine

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Terminated	2

Clinical Trial Sponsors for Norketamine

Sponsor Name

Sponsor Name
Sponsor	Trials
National Institute of Mental Health (NIMH)	2
Tampere University Hospital	1
University Medicine Greifswald	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Other	11
NIH	3
U.S. Fed	1