Ketorolac

Overview

Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and is commercially available as an oral tablet, injectable, nasal spray and as an ophthalmic solution. It's analgesic properties make it a useful pain management tool across many settings including postoperative pain, rheumatoid arthritis, osteoarthritis, menstrual disorders, headaches, spinal and soft tissue pain, and ankylosing spondylitis. Impressively, ketorolac has a similar efficacy to standard doses of morphine and meperidine making it a useful opioid sparing agent.

Indication

Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and has antipyretic, analgesic and anti-inflammatory properties. It is indicated for short term management of acute pain that requires the calibre of pain management offered by opioids. Clinicians may choose to initiate ketorolac to manage post-operative pain, spinal and soft tissue pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders and headaches among other ailments. Regardless of the etiology of pain, patients should use the lowest possible dose, and avoid using ketorolac for an extended period of time (ideally ≤ 5 days). A benefit of choosing ketorolac over other analgesics with similar potency is that that there does not appear to be a risk of dependence or tolerance with ketorolac use.

Associated Conditions

Acute Migraine
Eye Pain
Inflammation
Macular Edema, Cystoid
Ocular Itching
Pericarditis Acute
Pseudophakic Cystoid Macular Oedema
Severe Acute Pain
Acute, moderate Pain
Chronic aphakic cystoid macular edema
Intraoperative miosis
Postoperative ocular pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial	2025/06/26	NCT07037888	Phase 4	Recruiting	Henry Ford Health System
Optimizing Pain Treatment in Children On Mechanical Ventilation	2025/05/29	NCT06994442	Phase 3	Not yet recruiting	Weill Medical College of Cornell University
Non-Narcotic Pain Control After ACL Reconstruction	2025/05/15	NCT06973785	Phase 3	Recruiting	The Cleveland Clinic
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection	2025/05/13	NCT06968806	Phase 3	Not yet recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Oral Ketorolac for IUD Pain Reduction	2025/02/28	NCT06853327	Phase 2	ENROLLING_BY_INVITATION	University of North Carolina, Chapel Hill
Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study	2025/02/11	NCT06819956	Phase 3	Not yet recruiting	University of Alberta
Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries	2024/12/11	NCT06729047	Phase 1	Not yet recruiting	Assiut University
Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC	2024/11/08	NCT06681688	Phase 1	Recruiting	Inder Paul Singh, M.D.
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy	2024/10/22	NCT06653400	Phase 1	Recruiting	Icahn School of Medicine at Mount Sinai
The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.	2024/09/04	NCT06584188	Phase 2	Not yet recruiting	Ain Shams University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ketorolac Tromethamine	Asclemed USA, Inc.	76420-184	INTRAMUSCULAR	60 mg in 2 mL	10/12/2022
Ketorolac Tromethamine	Preferred Pharmaceuticals Inc.	68788-8504	ORAL	10 mg in 1 1	8/10/2023
KETOROLAC TROMETHAMINE	Steriscience Specialties Private Limited	82449-217	INTRAMUSCULAR	60 mg in 2 mL	7/5/2023
Ketorolac Tromethamine	American Health Packaging	60687-104	ORAL	10 mg in 1 1	9/13/2022
Dex-Moxi-Ketor	Imprimis NJOF, LLC	71384-513	OPHTHALMIC	0.4 mg in 1 mL	2/10/2020
Ketorolac Tromethamine	Hospira, Inc.	0409-3793	INTRAMUSCULAR, INTRAVENOUS	15 mg in 1 mL	1/4/2023
Ketorolac Tromethamine	Caplin Steriles Limited	65145-139	OPHTHALMIC	5 mg in 1 mL	3/30/2024
Ketorolac Tromethamine	Athenex Pharmaceutical Division, LLC.	70860-700	INTRAVENOUS, INTRAMUSCULAR	15 mg in 1 mL	3/4/2024
Ketorolac tromethamine	Henry Schein, Inc.	0404-9996	INTRAMUSCULAR, INTRAVENOUS	30 mg in 1 mL	8/29/2023
KETOROLAC TROMETHAMINE	Henry Schein, Inc.	0404-9952	INTRAVENOUS, INTRAMUSCULAR	15 mg in 1 mL	9/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Omidria	Rayner Surgical (Ireland) Limited,The Mill Enterprise Hub,Newtown Link Road,Drogheda,A92 CD3D,Co. Louth,Ireland	Authorised	7/28/2015

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
XEVOLAC SOLUTION FOR INJECTION 30 MG/ML	PT. Novell Pharmaceutical Laboratories	SIN16401P	INJECTION, SOLUTION	30 mg/ml	12/14/2021
ACULAR OPHTHALMIC SOLUTION 0.5%	ALLERGAN PHARMACEUTICALS IRELAND	SIN11189P	SOLUTION	0.5% w/v	10/11/1999
KETO FILM COATED TABLET 10 mg	YUNG SHIN PHARMACEUTICAL IND CO LTD	SIN10330P	TABLET, FILM COATED	10 mg	10/28/1998
KETOROLAC TROMETHAMINE INJECTION 30 mg/ml	HOSPIRA INC	SIN11340P	INJECTION	30 mg/ml	6/16/2000

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
KETOROLAC-BAXTER ketorolac trometamol 30 mg/1 mL solution for injection ampoule	218877	Baxter Healthcare Pty Ltd	Medicine	A	12/19/2014
KETOROLAC MEDSURGE ketorolac trometamol 30 mg/1 mL solution for injection ampoule	370164	Medsurge Pharma Pty Ltd	Medicine	A	6/8/2022
KETOROLAC MEDSURGE ketorolac trometamol 10 mg/1 mL solution for injection ampoule	370166	Medsurge Pharma Pty Ltd	Medicine	A	6/8/2022
KETOVINZ ketorolac trometamol 5 mg/mL eye drop bottle	396656	Micro Labs Pty Ltd	Medicine	A	7/18/2023
ACULAR ketorolac trometamol 5mg/mL eye drop bottle	63539	AbbVie Pty Ltd	Medicine	A	6/23/1998
KETOROLAC KABI ketorolac trometamol 30 mg/1 mL solution for injection, vial	275273	Fresenius Kabi Australia Pty Ltd	Medicine	A	4/28/2017
KETOROLAC MEDSURGE ketorolac trometamol 5 mg/mL eye drop bottle	396650	Micro Labs Pty Ltd	Medicine	A	7/18/2023
APO-KETOROLAC ketorolac trometamol 10 mg/1 mL solution for injection ampoule	217078	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/27/2014
KETOROLAC JUNO ketorolac trometamol 30 mg/1 mL solution for injection ampoule	211626	Juno Pharmaceuticals Pty Ltd	Medicine	A	8/20/2014
KETOMOL ketorolac trometamol 5 mg/mL eye drop bottle	396653	Micro Labs Pty Ltd	Medicine	A	7/18/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
KETOROLAC TROMETHAMINE INJECTION, USP	auro pharma inc	02521601	Solution - Intramuscular	30 MG / ML	N/A
TORADOL IM 30MG/ML	Hoffmann-La Roche Limited	02162652	Liquid - Intramuscular	30 MG / ML	12/31/1996
ACULAR	Abbvie Corporation	01968300	Solution - Ophthalmic	0.5 % / W/V	12/31/1992
KETOROLAC TROMETHAMINE INJECTION, USP	omega laboratories limited	02539357	Solution - Intramuscular	30 MG / ML	N/A
KETOROLAC TROMETHAMINE INJECTION USP	Pfizer Canada Ulc	02390582	Solution - Intramuscular	30 MG / ML	5/29/2014
TORADOL TAB 10MG	syntex inc.	00864048	Tablet - Oral	10 MG / TAB	12/31/1991
KETOROLAC TROMETHAMINE INJECTION USP	Sterimax Inc	02461129	Solution - Intramuscular	30 MG / ML	N/A
ACUVAIL	Abbvie Corporation	02369362	Solution - Ophthalmic	0.45 % / W/V	1/10/2012
RIVA-KETOROLAC 10 MG	laboratoire riva inc.	02242189	Tablet - Oral	10 MG / TAB	N/A
NU-KETOROLAC OPHTHALMIC SOLUTION	nu-pharm inc	02336693	Solution - Ophthalmic	0.5 %	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TORADOL 30 mg/1 ml SOLUCION INYECTABLE	Atnahs Pharma Netherlands Bv.	58976	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ACULAR 5 mg/ml COLIRIO EN SOLUCION	Abbvie Spain, S.L.U.	61690	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
KETOROLACO TROMETAMOL QUALIGEN 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Neuraxpharm Spain S.L.	70105	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
KETOROLACO KABI 30 MG/ML SOLUCION INYECTABLE EFG	Fresenius Kabi España, S.A.U.	84357	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
KETOROLACO TROMETAMOL NORMON 30 mg/ml SOLUCION INYECTABLE EFG	Laboratorios Normon S.A.	70102	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
KETOROLACO TROMETAMOL QUALIGEN 30 MG/ML SOLUCION INYECTABLE EFG	Neuraxpharm Spain S.L.	70103	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
KETOROLACO TROMETAMOL ACCORD 30 MG/ML SOLUCION INYECTABLE EFG	Accord Healthcare S.L.U.	70098	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
ACULAR COLIRIO	Allergan France	334 295-9	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized

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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