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Ketorolac (Ketorolac Tromethamine) - Summary

 
 



WARNING

Ketorolac tromethamine tablets, a non-steroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine should not exceed 5 days.

Ketorolac tromethamine tablets are not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.

GASTROINTESTINAL RISK

  • •Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

CARDIOVASCULAR RISK

  • •NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS  and CLINICAL STUDIES).
  • •Ketorolac tromethamine is CONTRAINDICATED for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

RENAL RISK

  • •Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS).

RISK OF BLEEDING

  • •Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).

Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.

RISK DURING LABOR AND DELIVERY

  • •The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions.

CONCOMITANT USE WITH NSAIDS

  • •Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

SPECIAL POPULATIONS

  • •Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS).
 

KETOROLAC SUMMARY

Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs).

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.

The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days


See all Ketorolac indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ketorolac (Ketorolac Tromethamine)

Pain, Papular Lesions, a Trip to Pakistan: Crack the Case
Source: Medscape Infectious Diseases Headlines [2015.08.19]
Dr Paget discusses one of his recent patients who returned from a trip to Pakistan 5 years ago and since then has never been the same.
Medscape Rheumatology

NeuroBreak: OxyContin for Kids, Singing Away the Pain
Source: MedPage Today Neurology [2015.08.18]
(MedPage Today) -- News and commentary from the world of neurology and neuroscience

Florida Laws May Help Lower Abuse of Prescription Painkillers
Source: MedicineNet Chronic Pain Specialty [2015.08.18]
Title: Florida Laws May Help Lower Abuse of Prescription Painkillers
Category: Health News
Created: 8/17/2015 12:00:00 AM
Last Editorial Review: 8/18/2015 12:00:00 AM

25 Million U.S. Adults Struggle With Daily Pain
Source: MedicineNet Chronic Pain Specialty [2015.08.18]
Title: 25 Million U.S. Adults Struggle With Daily Pain
Category: Health News
Created: 8/18/2015 12:00:00 AM
Last Editorial Review: 8/18/2015 12:00:00 AM

Yeast's New Use: Making Narcotic Painkillers
Source: MedicineNet Chronic Pain Specialty [2015.08.14]
Title: Yeast's New Use: Making Narcotic Painkillers
Category: Health News
Created: 8/13/2015 12:00:00 AM
Last Editorial Review: 8/14/2015 12:00:00 AM

more news >>

Published Studies Related to Ketorolac (Ketorolac Tromethamine)

Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. [2014]
postoperatively, but concerns over postoperative bleeding have limited its use... CONCLUSIONS: This is the first meta-analysis of randomized controlled trials

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial. [2014]
ketorolac for pain management during first-trimester surgical abortion... CONCLUSIONS: Intramuscular ketorolac does not offer superior pain control

Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. [2012]
randomized clinical trial... CONCLUSIONS: One month after uneventful phacoemulsification, there was no

The effect of perioperative ketorolac on pain control in pregnancy termination. [2011.11.29]
BACKGROUND: The study was conducted to evaluate the effect of perioperative ketorolac on pain associated with first-trimester aspiration abortion... CONCLUSION: Perioperative ketorolac has the same effect on postoperative pain as determined by VAS as placebo. The use of ketorolac at the 30-mg dose cannot be recommended for better pain control for patients undergoing first-trimester pregnancy termination by suction curettage. The only positive effect of the use of ketorolac compared to placebo was a reduction in the use of acetaminophen. Ketorolac use does not appear to change blood loss in the operating room or through postoperative day 1 compared to placebo. Copyright (c) 2011 Elsevier Inc. All rights reserved.

A randomized, controlled trial validates a peripheral supra-additive antihyperalgesic effect of a paracetamol-ketorolac combination. [2011.11]
The combination of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) is widely used; however, the nature and mechanism of their interaction are still debated. A double-blind, pharmacokinetic/pharmacodynamic, randomized, cross-over, placebo-controlled study was carried out in human healthy volunteers...

more studies >>

Clinical Trials Related to Ketorolac (Ketorolac Tromethamine)

Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery [Completed]
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.

Topical 0.4% Ketorolac and Vitreoretinal Surgery [Completed]
To determine whether use of topical 0. 4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation [Withdrawn]
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy [Recruiting]
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

Disposition of Intravenous Ketorolac [Not yet recruiting]
The purpose of this study is:

- to document ketorolac disposition (concentration/time profile, protein binding,

metabolism) and its covariates following intravenous (iv) administration of ketorolac right after caesarean section and to compare those observations (n=32) with non-pregnant state (n=8) (intra-subject PK comparison)

- to document biochemical tolerance of ketorolac

- to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are

appropriated and needed

- to quantify the neonatal exposure to ketorolac through excretion in the breast milk

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Ketorolac has an overall score of 7. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Ketorolac review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   pain, muscle strain
Dosage & duration:   1 tablet taken as needed, maybe once per week or month for the period of several years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   This works very well for mild to moderate pain, usually caused by over-exertion, and charaterized by muscle soreness, spasms, cramps, tightness
Side effects:   I did not personally have any problems with this medication, though like with any NSAID, stomach upset and liver damage certainly have to be considered.
Comments:   I just use this off and on for anytime i have pain and spasms most generally associated with over - exertion

See all Ketorolac reviews / ratings >>

Page last updated: 2015-08-19

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