MedPath

Ketorolac

Generic Name
Ketorolac
Brand Names
Acular, Acuvail, Omidria, Readysharp Anesthetics Plus Ketorolac, Sprix, Toradol, Toronova Suik
Drug Type
Small Molecule
Chemical Formula
C15H13NO3
CAS Number
74103-06-3
Unique Ingredient Identifier
YZI5105V0L
Background

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
Associated Therapies
-

Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome

Not Applicable
Withdrawn
Conditions
Subacromial Bursitis
Subacromial Impingement Syndrome
Interventions
First Posted Date
2011-10-10
Last Posted Date
2016-11-04
Lead Sponsor
Madigan Army Medical Center
Registration Number
NCT01449448

Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

Phase 3
Terminated
Conditions
Laparoscopic Surgery
Interventions
Drug: N1539
Drug: Ketorolac Tromethamine
Drug: Placebo
First Posted Date
2011-09-19
Last Posted Date
2012-03-14
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
50
Registration Number
NCT01436032
Locations
🇺🇸

Lotus Clinical Research LLC, Pasadena, California, United States

Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2011-06-03
Last Posted Date
2013-02-06
Lead Sponsor
American Regent, Inc.
Target Recruit Count
30
Registration Number
NCT01365624
Locations
🇺🇸

Seaview Research, Miami, Florida, United States

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2011-06-03
Last Posted Date
2017-03-15
Lead Sponsor
Egalet Ltd
Target Recruit Count
36
Registration Number
NCT01365611
Locations
🇬🇧

ICON Development Solutions, Manchester, United Kingdom

Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis

First Posted Date
2011-06-03
Last Posted Date
2018-03-06
Lead Sponsor
Egalet Ltd
Target Recruit Count
24
Registration Number
NCT01365650
Locations
🇦🇺

Pain and Anaesthesia Research Clinic/Royal Adelaide Hospital, Adelaide, Australia

Study to Assess the PK of Ketorolac Tromethamine Intranasal and to Assess the Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine

Phase 1
Completed
Conditions
Assess Pharmacokinetics of Ketorolac Tromethamine Intranasal and Assess Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine
Interventions
First Posted Date
2011-06-01
Last Posted Date
2017-02-09
Lead Sponsor
Egalet Ltd
Target Recruit Count
21
Registration Number
NCT01363089
Locations
🇬🇧

ICON Development Solutions, Manchester, United Kingdom

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

Phase 1
Completed
Conditions
Postoperative Pain
Interventions
First Posted Date
2011-06-01
Last Posted Date
2017-03-16
Lead Sponsor
Egalet Ltd
Target Recruit Count
20
Registration Number
NCT01363076
Locations
🇺🇸

Stanford University Medical Center, Stanford, California, United States

Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2011-06-01
Last Posted Date
2017-03-16
Lead Sponsor
Egalet Ltd
Target Recruit Count
15
Registration Number
NCT01363050
Locations
🇬🇧

Medeval Limited, Manchester, United Kingdom

Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2011-06-01
Last Posted Date
2018-03-06
Lead Sponsor
Egalet Ltd
Target Recruit Count
40
Registration Number
NCT01363063
Locations
🇬🇧

ICON Developmental Solutions, Manchester, United Kingdom

Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2011-05-19
Last Posted Date
2017-02-08
Lead Sponsor
Egalet Ltd
Target Recruit Count
13
Registration Number
NCT01356212
Locations
🇬🇧

Pharmaceutical Profiles, Ltd, Ruddington, Nottingham, United Kingdom

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