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Toradol (Ketorolac Tromethamine) - Summary

 



WARNING

TORADOL, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. It is NOT indicated for minor or chronic painful conditions. TORADOL is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom TORADOL is indicated, especially when the drug is used inappropriately. Increasing the dose of TORADOL beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.

GASTROINTESTINAL EFFECTS

- TORADOL can cause peptic ulcers, gastrointestinal bleeding and/or perforation. Therefore, TORADOL 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.

RENAL EFFECTS

- TORADOL 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

- TORADOL 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).

- TORADOL is CONTRAINDICATED as prophylactic analgesic before any major surgery and is CONTRAINDICATED intraoperatively when hemostasis is critical because of the increased risk of bleeding.

HYPERSENSITIVITY

- Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of TORADOLIV/IM(see CONTRAINDICATIONS and WARNINGS). TORADOL is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

INTRATHECAL OR EPIDURAL ADMINISTRATION

- TORADOL is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.

LABOR, DELIVERY AND NURSING

- The use of TORADOL in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.

- The use of TORADOL is CONTRAINDICATED in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.

CONCOMITANT USE WITH NSAIDs

- TORADOL is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

DOSAGE AND ADMINISTRATION

TORADOLORAL

- TORADOLORALis indicated only as continuation therapy to TORADOL IV/IM, and the combined duration of use of TORADOL IV/IMand TORADOL ORALis not to exceed 5 days because of the increased risk of serious adverse events.

- The recommended total daily dose of TORADOL ORAL(maximum 40 mg) is significantly lower than for TORADOL IV/IM(maximum 120 mg) (see DOSAGE AND ADMINISTRATION and Transition from TORADOL IV/IMto TORADOL ORAL).

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). Doses of TORADOL IV/IMare not to exceed 60 mg (total dose per day) in these patients. TORADOL IV/IMis indicated as a single dose therapy in pediatric patients (see DOSAGE AND ADMINISTRATION); not to exceed 30 mg for IM administration and 15 mg for IV administration.

 

TORADOL SUMMARY

TORADOL (ketorolac tromethamine) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs).

TORADOL is 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.
See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Toradol (Ketorolac)

62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.


Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.

CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.

Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.

FDA Approves New Drug For Pain That Persists After Shingles
Source: Dermatology News From Medical News Today [2009.11.18]
The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.

more news >>

Published Studies Related to Toradol (Ketorolac)

Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. [2009.07]
OBJECTIVES: Postoperative ileus (PI) is one of many common complications in major abdominal surgery... We suggest that adding ketorolac to morphine IVPCA be included in the multimodal postoperative rehabilitation program for the early restoration of normal bowel function.

Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK. [2009.02]
PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK)... CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.

Efficacy of pocket irrigation with bupivacaine and ketorolac in breast augmentation: a randomized controlled trial. [2009.01]
Breast augmentation is the most common cosmetic surgery procedure performed in the United States. The optimal approach to postoperative pain management in these patients, however, has yet to be determined... These findings suggest that intraoperative administration of analgesics into the implant pocket may thus facilitate an early postoperative recovery; yet, patients should be advised that they might require more pain medication at home for the first few days.

The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. [2008.12]
BACKGROUND: We evaluated the safety and efficacy of multiple doses of intranasal ketorolac tromethamine (ketorolac) for postoperative pain... CONCLUSION: Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.

Postoperative intravenous patient-controlled analgesia in thyroid surgery: comparison of fentanyl and ondansetron regimens with and without the nonsteriodal anti-inflammatory drug ketorolac. [2008.12]
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs), through synergistic action with opioids, can reduce postoperative nausea and vomiting via intravenous patient-controlled analgesia (PCA). We compared the efficacy of three PCA regimens... CONCLUSIONS: The NSAID ketorolac when combined with lower doses of the opioid fentanyl and the same dose of ondansetron is associated with the same analgesic efficacy but less nausea and vomiting after thyroid surgery. A higher ratio of NSAID to opioid, when used as reported here, is associated with less postoperative dizziness.

more studies >>

Clinical Trials Related to Toradol (Ketorolac)

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.

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity [Enrolling by invitation]
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity. In this study ACULAR will be compared to a placebo (artificial tear).

The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

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.

Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema. [Active, not recruiting]
This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision.

The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. We want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management [Recruiting]
After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures.

The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Toradol has an overall score of 2. The effectiveness score is 5 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
 

Toradol review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   pain relief after surgery
Dosage & duration:   10 mg taken every 6 hours for the period of one day
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I took this drug for pain relief due to surgery (laproscopically assisted hysterectomy). Although the pain I experienced wasn't great the drug did relieve it but the side effects were not worth it.
Side effects:   It's hard to know as I was swollen from the surgery but the drug's listed side effects are swelling if the torso, thighs, and legs. I was very swollen when I left the hospital and it didn't dissapate.
Comments:   I was given the drug intravenously while in the hospital and a perscription when I went home. I was swollen from my breasts to my toes and attributed this to the surgery.I had told my doctor that I couldn't tolerate a high does of ibuprofen so she prescribed the generic toradol as pain relief. When the swelling showed no signs of abating, I looked up the drug's side effects and saw that swelling of the torso, thighs and legs was listed. I was trying to reduce the swelling so I stopped taking it and switched to 1 ibuprofen 4 times a day. That relieved the pain and the swelling immediately started to go down. When I told my doctor she said swelling of the torso was not a normal effect of the surgery. I conclude that the drug was at fault.

 

Toradol review by medical professional caring for 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   for back pain
Dosage & duration:   one amp. (dosage frequency: once) for the period of once
Other conditions:   NO
Other drugs taken:   morphina
  
Reported Results
Benefits:   None. She did an anaphylaxis schock and she did not receive any benefit .
Side effects:   Shock anaphylactic
Comments:   It was used for back pain . She did a severe reaction ( anaphylactic schock). We did the right treatment . We use adrenaline and IV solutions inmediately, we have to transport the patient to the more big hospital in our city and she was at intense care unit by 5 days. She is outside now , but she got as aftermath an Asthma and she is using Inhalator.

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Page last updated: 2009-11-19

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