Ketamine

Overview

Ketamine is an NMDA receptor antagonist with a potent anesthetic effect. It was developed in 1963 as a replacement for phencyclidine (PCP) by Calvin Stevens at Parke Davis Laboratories. It started being used for veterinary purposes in Belgium and in 1964 was proven that compared to PCP, it produced minor hallucinogenic effects and shorter psychotomimetic effects. It was FDA approved in 1970, and from there, it has been used as an anesthetic for children or patients undergoing minor surgeries but mainly for veterinary purposes.

Indication

Ketamine is indicated as an anesthetic agent for recommended diagnostic and surgical procedures. If skeletal muscle relaxation is needed, it should be combined with a muscle relaxant. If the surgical procedure involves visceral pain, it should be supplemented with an agent that obtunds visceral pain. Ketamine can be used for induction of anesthesia prior other general anesthetic agents and as a supplement of low potency agents. Reports have indicated a potential use of ketamine as a therapeutic tool for the management of depression when administered in lower doses. These reports have increased the interest for ketamine in this area and several clinical trials are launched for this indication.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures	2025/08/13	NCT07120763	Not Applicable	Not yet recruiting	State University of New York at Buffalo
Chart Review of Patients Undergoing Ketamine Treatments for Depression	2025/08/01	NCT07099235	N/A	Completed	Sunnybrook Health Sciences Centre
Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)	2025/07/31	NCT07095842	Not Applicable	Recruiting	Sohag University
Ketamine Augmentation of ECT in Treatment-Resistant Depression	2025/07/28	NCT07088380	Not Applicable	Recruiting	Università Vita-Salute San Raffaele
Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy	2025/07/24	NCT07084753	Not Applicable	Not yet recruiting	IVO JURISIC
Comparison Between the Effect of Dexmedetomidine _midazolam and ketamine_midazolam Combination	2025/07/20	NCT07074262	Not Applicable	Completed	Beni-Suef University
Effects of Local Ketamine in Orthognathic Procedures	2025/07/15	NCT07066306	Not Applicable	Active, not recruiting	Bezmialem Vakif University
Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty	2025/07/10	NCT07059429	Not Applicable	Not yet recruiting	State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Pre-emptive Analgesia Using Nebulized Ketamine Versus Nebulized Dexmedetomidine in Endoscopic Nasal Surgeries	2025/07/09	NCT07056582	Not Applicable	Recruiting	Sohag University
Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia	2025/07/09	NCT07055828	Not Applicable	Active, not recruiting	Tanta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ketamine Hydrochloride	Medical Purchasing Solutions, LLC	71872-7258	INTRAMUSCULAR, INTRAVENOUS	100 mg in 1 mL	4/27/2023
MKO Melt Dose Pack	Imprimis NJOF, LLC	71384-410	SUBLINGUAL	25 mg in 1 1	3/4/2019
Ketamine Hydrochloride	Hospira, Inc.	0409-2053	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	7/15/2022
Ketamine Hydrochloride	Sagent Pharmaceuticals	25021-682	INTRAVENOUS, INTRAMUSCULAR	10 mg in 1 mL	5/1/2023
Ketamine Hydrochloride	Gland Pharma Limited	68083-504	INTRAVENOUS, INTRAMUSCULAR	10 mg in 1 mL	2/23/2023
Ketamine Hydrochloride	Physicians Total Care, Inc.	54868-4399	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	4/23/2012
KETALAR	General Injectables & Vaccines, Inc	52584-037	INTRAVENOUS, INTRAMUSCULAR	10 mg in 1 mL	12/22/2022
Ketamine Hydrochloride	Gland Pharma Limited	68083-505	INTRAVENOUS, INTRAMUSCULAR	50 mg in 1 mL	2/23/2023
KETAMINE HYDROCHLORIDE	Eugia US LLC	55150-440	INTRAVENOUS, INTRAMUSCULAR	100 mg in 1 mL	2/3/2024
Ketalar	Par Pharmaceutical, Inc.	42023-113	INTRAMUSCULAR, INTRAVENOUS	10 mg in 1 mL	12/18/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
KETAMINE HAMELN INJECTION 50 MG/ML	Siegfried Hameln GmbH	SIN15402P	INJECTION, SOLUTION	50 MG	1/9/2018
KETAMINE HYDROCHLORIDE INJECTION USP	PANPHARMA GmbH	SIN05966P	INJECTION	50 mg/ml	5/23/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
KETALAR ketamine 200mg/2mL (as hydrochloride) injection vial	128805	Hospira Australia Pty Ltd	Medicine	A	6/20/2006
KETALAR ketamine 200mg/2mL (as hydrochloride) injection vial	70073	Pfizer Australia Pty Ltd	Medicine	A	2/14/2000
KETAMINE INTERPHARMA ketamine (as hydrochloride) 20 mg/2 mL solution for injection ampoule	310918	Interpharma Pty Ltd	Medicine	A	12/16/2019
APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule	219039	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/12/2014
BIOMED KETAMINE ketamine (as hydrochloride) 100 mg/100 mL injection for IV infusion bag	319220	Biomed Aust Pty Ltd	Medicine	A	6/22/2020
KETAMINE INTERPHARMA ketamine (as hydrochloride) 250 mg/5 mL solution for injection ampoule	310912	Interpharma Pty Ltd	Medicine	A	12/16/2019
KETAMINE-BAXTER ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule	219960	Baxter Healthcare Pty Ltd	Medicine	A	2/4/2015
KETAMINE INTERPHARMA ketamine (as hydrochloride) 50 mg/5 mL solution for injection ampoule	310910	Interpharma Pty Ltd	Medicine	A	12/16/2019
KETAMINE INTERPHARMA ketamine (as hydrochloride) 500 mg/10 mL solution for injection ampoule	310916	Interpharma Pty Ltd	Medicine	A	12/16/2019
KETAMINE INTERPHARMA ketamine (as hydrochloride) 100 mg/10 mL solution for injection ampoule	310913	Interpharma Pty Ltd	Medicine	A	12/16/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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