KETAMINE SUMMARY
Ketamine Hydrochloride Injection, USP
Ketamine hydrochloride is a nonbarbiturate anesthetic chemically
designated (±)-2-(o -Chlorophenyl)-2-(methylamino)
cyclohexanone hydrochloride. It is formulated as a slightly acid (pH 3.5 to
5.5) sterile solution for intravenous or intramuscular injection in concentrations
containing the equivalent of either 50 or 100 mg ketamine base per milliliter
and contains not more than 0.1 mg/mL benzethonium chloride added as a preservative.
Ketamine hydrochloride injection is indicated as the sole
anesthetic agent for diagnostic and surgical procedures that do not require
skeletal muscle relaxation. Ketamine hydrochloride injection is best suited
for short procedures but it can be used, with additional doses, for longer
procedures.
Ketamine hydrochloride injection is indicated
for the induction of anesthesia prior to the administration of other general
anesthetic agents.
Ketamine hydrochloride injection
is indicated to supplement low-potency agents, such as nitrous oxide.
Specific
areas of application are described in the CLINICAL
PHARMACOLOGY section.
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NEWS HIGHLIGHTSMedia Articles Related to Ketamine
Can the Anesthetic Ketamine Ease Suicidal Thoughts? Source: MedicineNet Electroconvulsive Therapy Specialty [2016.05.11] Title: Can the Anesthetic Ketamine Ease Suicidal Thoughts? Category: Health News Created: 5/10/2016 12:00:00 AM Last Editorial Review: 5/11/2016 12:00:00 AM
Published Studies Related to Ketamine
Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine,
and 4:1 propofol/ketamine for deep procedural sedation in the emergency
department. [2015] propofol and ketamine (ketofol)... CONCLUSION: We found a similar frequency of airway and respiratory adverse events
Neurocognitive effects of ketamine and association with antidepressant response
in individuals with treatment-resistant depression: a randomized controlled
trial. [2015] The glutamate N-methyl-D-aspartate (NMDA) receptor antagonist ketamine displays
rapid antidepressant effects in patients with treatment-resistant depression
(TRD); however, the potential for adverse neurocognitive effects in this
population has not received adequate study...
A phase III randomized, placebo-controlled study of topical amitriptyline and
ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of
Rochester CCOP study of 462 cancer survivors. [2014] efficacy of 2% ketamine plus 4% amitriptyline (KA) cream for reducing CIPN... CONCLUSIONS: This study suggests that KA cream does not decrease CIPN symptoms in
Effects of intra-operative ketamine administration on postoperative
catheter-related bladder discomfort: a double-blind clinical trial. [2014] postoperative period when compared to placebo... CONCLUSION: Preemptive administration of IV ketamine (0.5 mg/kg) can reduce
Low-dose ketamine improves pain relief in patients receiving intravenous opioids
for acute pain in the emergency department: results of a randomized,
double-blind, clinical trial. [2014] patients... CONCLUSIONS: Low-dose ketamine is a viable analgesic adjunct to morphine for the
Clinical Trials Related to Ketamine
Ketamine Associated With Morphine PCA After Total Hip Arthroplasty [Completed]
Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid
Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that
ketamine administrated separately via a continuous infusion, could induced a better
analgesic effect.
We will perform a randomised double blind study to determine the best infusion mode of
intravenous ketamine, associated with morphine in PCA syringe or alone in continuous
infusion.
Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department [Completed]
This study aims to address both the management and evaluation of pain. The primary aim of
this study is to determine the efficacy of low dose ketamine in adults with moderate to
severe pain in the emergency department as compared with parenteral opioids alone. Another
aim is to examine the safety of low dose ketamine compared to opioids alone.
The investigators hypothesize that low dose ketamine will result in more effective pain
control than morphine alone and will not be associated with an increase in adverse events.
Methadone and Ketamine for Neuropathic Pain Treatment [Completed]
Methadone and ketamine are effective for neuropathic pain management. However, the benefits
of the association of both drugs are uncertain. Here, the investigators conducted a
randomized, double-blind, in parallel, active controlled clinical trial to test the
hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than
methadone or ketamine alone in reducing neuropathic pain.
Emergency Ketamine Treatment of Suicidal Ideation [Not yet recruiting]
The objective of the current program of research will be to test whether intranasal ketamine
treatment is more effective than placebo in reducing suicidal ideation in suicidal patients
presenting for acute treatment in emergency department settings. Secondary objectives will
test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine
and the correlation of speech patterns and facial movement patterns with subjective
reductions in suicidal ideation after ketamine treatment.
Action of Ketamine in Treatment-Resistant Depression [Recruiting]
Depression carries the largest burden of all medical disorders in middle to high income
countries, as determined by the World Health Organization. Despite many antidepressant
strategies, only a third of patients get well after their first treatment and a third remain
ill after several treatments. Moreover, antidepressant treatments all have a delayed action
ranging up to several weeks.
Ketamine (KET) has been used for decades as a sedative and anesthetic. In
treatment-resistant depressed patients(TRD), an intravenous dose much lower than necessary
for anesthesia may produce a robust antidepressant effect and may even abolish suicidal
thoughts within hours, peaking within 24 hours. But, its antidepressant effect generally
lasts only days. Previous studies examining KET in TRD have been critiqued for lack of an
effective placebo measure due to brief perceptual experiences associated with KET. Thus, the
current study compares KET against a short-acting sedative. The phases of this study compare
response to a single KET injection to 6 injections over 2 weeks. Next, KET responders are
given 1 injection a week for 3 weeks of either KET or the sedative agent to determine if
beneficial effects of KET are maintained, and to assess duration of its benefits after
repeated administration. The genetic profile of patients for a substance promoting contacts
between cells and brain will be determined to investigate if response to KET could be
predicted with that blood test. This substance, as well as several chemicals that produce
inflammation, will also be measured in the blood to investigate their role in the effect of
KET. Patients will receive, in total, no more than the equivalent of two to three anesthetic
dose of KET. Results from this study will help establish the beneficial effects of a single
KET injection as a rapid intervention for major depression, and to investigate the
possibility of obtaining a prolonged antidepressant effect with repeated injections.
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