Naproxen With Cyclobenzaprine or Oxycodone Acetaminophen for Acute Low-Back Pain
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, inflammation, and fever. Other NSAIDs include ibuprofen (Motrin), indomethacin (Indocin), nabumetone (Relafen), and several others.
Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.
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The number needed to harm (NNH) is presented with a 95% CI when naproxen + active medication resulted in a statistically significant increase in adverse events compared with naproxen + placebo. Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting. This approach may lead to uncertainty with regard to interpretation of the data when some of the outcomes result in a statistically significant benefit and others do not.
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We also excluded patients who were pregnant or lactating, unavailable for follow-up, with allergy or contraindication to the investigational medications, or had chronic opioid use currently or in the past. Low back pain is a common ED presentation, resulting in 2.3% of all ED visitsReference Friedman, Chilstrom and Bijur 1 . Additionally, 69% reported daily analgesic use at one week, while 46% were still using analgesics at three monthsReference Friedman, O’Mahony and Mulvey 2 . We aimed to maximize medication use by instructing patients to choose whether to take 1 or 2 tablets of the investigational medication at each dosing, thereby giving the patient the ability to titrate efficacy against adverse effects. Infrequent use of the study medication is both a limitation and strength of this study—it is possible that standing doses of oxycodone/acetaminophen or cyclobenzaprine may have treated the pain and functional impairment more effectively.
- Measures of pain, functional impairment, and use of health care resources were not different between the study groups at 7 days or at 3 months after the ED visit.
- Pain control is essential to ensure patient comfort, to promote pulmonary toilet, and to aid physical therapy regimens.
- Taking the medication every six hours may increase pain control at the risk of increased side effects.
- Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.
- Overall, the study demonstrated no significant difference in functional outcomes at seven days or three months.
Cyclobenzaprine is best used in short-term treatment but may be used intermittently or long-term for chronic pain. Finally, approximately 24% of the patients still had moderate or severe low back pain at 3-month follow-up, suggesting that a number of patients will have prolonged pain irrespective of the acute medication given. In these patients, encouraging activity and ensuring primary care follow-up may be the most important ED interventionsReference Hagen, https://flexeril.live Jamtvedt and Hilde 10 . Among the patients who used the cyclobenzaprine, oxycodone/acetaminophen, or placebo investigational medication more than once, there was no significant difference in the primary outcome (eTable 1 in Supplement 2). Patients randomized to oxycodone/acetaminophen were more likely than those randomized to placebo to report pain levels of mild or none (difference, 18% [95% CI, 3% to 33%]; number needed to treat, 6 [95% CI, 3 to 37]).
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Measures of pain, functional impairment, and use of health care resources were not different between the study groups at 7 days or at 3 months after the ED visit. Regardless of allocation, nearly two-thirds of patients demonstrated clinically significant improvement in LBP and function 1 week later. However, 40% of the cohort reported moderate or severe pain, half reported functionally impairing LBP, and nearly 60% were still using medication for their LBP 1 week later.
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Additionally, there was a significant rate of side effects and 24% of patients still had back pain at three months. However, it is unclear if a significant difference would have been noted in the initial hours after presentation. This study provides valuable information to consider when discussing medication regimens with patients and can inform shared decision making between provider and patient when selecting discharge prescriptions.
Our results are similar to other studies of NSAIDs combined with cyclobenzaprine8,10,11,18 conducted in a variety of settings, including an ED and primary care and specialty clinics. Despite the fact that both NSAIDS and cyclobenzaprine are efficacious when administered as monotherapy,5,19 the bulk of the data, including the findings in this study, suggest combination therapy is not better than monotherapy. Additional data for the exploratory outcomes of pain intensity at one week follow-up and resumption of usual activities at three month follow-up are reported in eTable 2 in Supplement 2. Research personnel provided each patient with a 10-minute educational intervention based on information from the National Library of Medicine.15 Research personnel reviewed the topic with the patient in English or Spanish and answered questions.
Each participant was informed that carefully chosen exercises and stretches may help alleviate pain and prevent future occurrences and that hot or cold packs, physical therapy, massage therapy, and acupuncture help some patients. A drug combination indicated for the relief of moderate to severe pain. Before using this medication, report the use of drugs that increase serotonin, including street drugs (such as MDMA/»ecstasy»), St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), tramadol, among others. The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor.
By 3-month follow-up, nearly one-fourth of the cohort reported moderate or severe pain and use of medications for LBP. Three months after the ED visit, regardless of study group, opioid use for LBP was uncommon, with fewer than 3% of patients reporting use of an opioid within the previous 72 hours. It is important to note that only 63% of the patients took the naproxen as prescribed. Additionally, only 62% of the patients took the study medication at least once per day, with 8% of the patients taking the medication only one time and 16% of the patients never taking the medication at all.