Ketorolac Tromethamine

Short-Term Pain Management

Ketorolac tromethamine is used to treat moderately severe acute pain that would otherwise require opioid-level relief. It is most frequently used in hospital or clinical settings to manage pain immediately following surgical procedures. It works by blocking the body's production of certain natural substances that cause inflammation and pain.

How It Is Administered

Treatment typically begins with an injection given into a muscle or a vein by a healthcare professional. Depending on the clinical situation, treatment may be continued using oral tablets or a nasal spray. Regardless of the form used, the total duration of treatment must not exceed 5 days.

Usage Limitations

Because of the risk of serious side effects when used long-term, ketorolac is subject to several limitations:

• Acute Pain Only: It is intended for sudden, severe pain rather than chronic conditions like arthritis.
• Not for Minor Pain: It is not used for minor aches, pains, or low-level discomfort.
• Short Duration: It is strictly limited to a maximum of 5 days of use.
• Surgical Restrictions: It is not used for pain management before or during surgery, or for pain associated with certain heart bypass procedures.

Mechanism of Action

Ketorolac tromethamine belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of certain natural substances that cause pain, fever, and inflammation.

The medication specifically targets enzymes called cyclooxygenase (COX-1 and COX-2). These enzymes are responsible for creating prostaglandins, which are hormone-like chemicals produced at sites of tissue damage or infection. Prostaglandins play a major role in the body's healing process, but they also cause:

• Pain signals to be sent to the brain
• Inflammation and swelling
• Fever

By inhibiting these enzymes and reducing the level of prostaglandins, ketorolac helps to decrease the intensity of pain and reduce swelling. It is typically used for the short-term management of moderately severe acute pain. While it is a potent pain reliever, it is not a narcotic and does not affect the central nervous system in the same way that opioid medications do.

Common Side Effects

Many people using ketorolac experience mild side effects. These may include:

• Headache, dizziness, or drowsiness
• Nausea, indigestion, or stomach pain
• Diarrhea, constipation, or gas
• Sweating
• Sores in the mouth

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Fever, skin rash, or blisters
• Unexplained weight gain or swelling in the hands, feet, or ankles
• Yellowing of the skin or eyes
• Extreme fatigue or loss of appetite
• Dark-colored urine or pain when urinating
• Fast heartbeat or shortness of breath
• Pale skin
• Blurred vision or other vision changes

Boxed Warning: Short-Term Use Only

Ketorolac is intended only for the short-term management of moderately severe acute pain. The total duration of use, including both injection and oral forms, must not exceed five days. It is not appropriate for minor or long-term (chronic) pain.

Gastrointestinal Risks

This medication can cause serious stomach and intestinal problems, including bleeding, ulcers, and holes (perforation) in the stomach or intestines. These conditions can be fatal and may occur without warning. The risk is higher for older adults and those with a history of stomach ulcers or bleeding.

Heart and Blood Vessel Risks

Ketorolac may increase the risk of serious heart-related events, such as heart attack or stroke, which can be fatal. This risk may increase with longer use. It must not be used for pain relief before or after heart bypass surgery (CABG).

Kidney and Fluid Concerns

Ketorolac can cause kidney damage. It is not recommended for people with advanced kidney disease or those who are severely dehydrated. It may also cause the body to retain fluid, which can worsen heart failure or high blood pressure.

Bleeding Risks

Because ketorolac interferes with how blood clots, it increases the risk of bleeding. It should not be used by people with active bleeding, bleeding disorders, or those at high risk of bleeding after surgery.

Other Important Precautions

• Allergies: It should not be used by individuals with a history of asthma, hives, or allergic reactions to aspirin or other NSAIDs.
• Pregnancy and Labor: Ketorolac is not for use during labor or delivery because it may affect the baby's circulation or interfere with contractions.
• Drug Interactions: It should not be taken with other NSAIDs, pentoxifylline, or probenecid.

Pregnancy Considerations

Ketorolac should not be used during pregnancy unless specifically directed by a healthcare provider. Use of this medication starting at 20 weeks of pregnancy may cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid.

Using ketorolac at 30 weeks of pregnancy or later is contraindicated. At this stage, the medication can cause the premature closure of the ductus arteriosus, a blood vessel in the baby's heart. This can result in serious heart and lung complications for the newborn.

Ketorolac is also not recommended for use during labor and delivery. It may delay the start of labor, inhibit uterine contractions, and increase the risk of bleeding for both the mother and the baby.

Breastfeeding Considerations

Ketorolac is excreted into human breast milk. Due to the risk of serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the medication to the mother. Patients should consult with their healthcare provider to discuss safe alternatives or management strategies.

Available Forms

Ketorolac tromethamine is provided in the following forms:

• Oral: Tablets.
• Injectable: Solution for intramuscular or intravenous injection.
• Nasal: Nasal spray.
• Ophthalmic: Ophthalmic solution (eye drops).

FDA Approval and Indications

Ketorolac tromethamine is approved by the U.S. Food and Drug Administration (FDA) for the short-term management of moderately severe acute pain that requires analgesia at the opioid level. It is typically initiated as an intravenous (IV) or intramuscular (IM) injection and may be followed by oral tablets if necessary. The total duration of treatment for all forms of ketorolac combined must not exceed five days.

Boxed Warnings

The FDA requires a boxed warning for ketorolac due to the potential for serious and life-threatening adverse effects. These warnings include:

• Gastrointestinal Risk: There is an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation, which can be fatal. These events can occur at any time during use and without warning symptoms.
• Cardiovascular Risk: NSAIDs, including ketorolac, may cause an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke.
• Renal Risk: Ketorolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
• Bleeding Risk: Ketorolac inhibits platelet function and may increase the risk of bleeding. It is contraindicated as a prophylactic analgesic before major surgery and for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Labor, Delivery, and Nursing: Ketorolac is contraindicated during labor and delivery and in nursing mothers because of the potential adverse effects on the cardiovascular system of the fetus or newborn.

Usage Limitations

Ketorolac is not indicated for minor or chronic painful conditions. Because of its significant safety profile, it is only intended for patients who require potent pain relief for a very limited time. It is contraindicated in patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation, and a history of hypersensitivity to aspirin or other NSAIDs.