What is the best course of action for managing nocturnal bone pain in a patient with a left femoral intramedullary rod, currently taking naproxen (Nonsteroidal Anti-Inflammatory Drug)?

From the Guidelines

I strongly recommend discontinuing naproxen 375mg BID KOP and replacing it with a more suitable pain management regimen, considering the patient's nighttime bone pain and potential risks associated with naproxen overuse. The patient's current medication regimen, including naproxen, has not provided adequate pain relief, and the patient's reported overuse of naproxen poses significant risks for gastrointestinal bleeding and kidney injury 1.

Medication Regimen

• Indomethacin 50mg BID DOT may be considered as an alternative NSAID, but its use should be carefully weighed against potential gastrointestinal and cardiovascular risks, as highlighted in recent studies 1.
• Acetaminophen 325mg BID can provide additional pain relief through a different mechanism, with a more favorable safety profile compared to NSAIDs 1.
• A short course of prednisone 40mg daily for three days may help reduce inflammation, but its use should be limited to the shortest duration necessary to minimize potential side effects.

Administration and Monitoring

• All medications should be administered as directly observed therapy (DOT) rather than keep-on-person (KOP) to ensure proper medication adherence and prevent potential overuse.
• The patient's pain pattern, which is worse at night despite being on his feet all day, is somewhat unusual and may warrant further investigation for other causes if this regimen doesn't provide relief.

Considerations and Precautions

• The use of NSAIDs, including indomethacin, should be carefully considered in light of potential gastrointestinal and cardiovascular risks, as highlighted in recent studies 1.
• The patient's medication regimen should be regularly reviewed and adjusted as necessary to minimize potential risks and optimize pain management.

From the FDA Drug Label

DOSAGE & ADMINISTRATION ... Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals The recommended dose is 250 mg, 375 mg, or 500 mg twice daily The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary Although naproxen tablets, naproxen suspension, naproxen delayed-released tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action

• The patient is currently taking naproxen 375mg BID and sometimes takes 6 tabs at night, which exceeds the recommended daily dose.
• The plan to discontinue naproxen and switch to Indomethacin may be appropriate given the patient's excessive dosage.
• It is also prudent to consider the patient's renal function before prescribing any new medication, especially NSAIDs like Indomethacin, as naproxen is not recommended for use in patients with moderate to severe renal impairment 2.
• The prescription of acetaminophen 325 mg BID and a course of prednisone 40 mg for three days may help manage the patient's pain.

From the Research

Patient's Condition and Treatment

• The patient is a 31-year-old male with a left femoral intramedullary rod, experiencing 8/10 pain at night that is deep to the bone.
• The patient works all day on his feet but denies pain during the day.
• The patient is currently taking naproxen 375mg BID KOP and sometimes takes 6 tabs at night.

Discontinuation of Naproxen and New Prescriptions

• The plan is to discontinue the naproxen and place an order for Indomethacin 50 mg BID DOT, as seen in studies such as 3 which discusses the efficacy of indomethacin in managing mild-to-moderate pain.
• Acetaminophen 325 mg BID and a course of prednisone 40 mg for three days will also be prescribed.
• No KOP medications will be prescribed for this patient as a precaution.

Considerations for NSAID Use

• Studies such as 4 and 5 highlight the potential risks associated with long-term NSAID use, including gastrointestinal and cardiovascular complications.
• The patient's current naproxen use and potential for increased dosage may contribute to these risks, as discussed in 4 which evaluated the long-term safety of naproxen and esomeprazole magnesium fixed-dose combination.
• The decision to discontinue naproxen and prescribe indomethacin may be influenced by the need to balance pain management with the potential risks associated with NSAID use, as outlined in 6 which provides a comprehensive review of NSAID-induced organ damage.

Rationale for Indomethacin Prescription

• Indomethacin has been shown to be effective in managing mild-to-moderate pain, as discussed in 3.
• The prescription of indomethacin 50 mg BID DOT may be intended to provide adequate pain management while minimizing the risks associated with NSAID use.
• However, it is essential to consider the patient's individual needs and medical history when prescribing indomethacin, as well as monitoring for potential side effects and adjusting the treatment plan as necessary.