November 08, 2017
Patients presenting to the emergency department (ED) who are in moderate to severe pain resulting from acute arm or leg injuries report similar pain relief from a combination of over-the-counter pain medications as they do from narcotic pain killers, a randomized controlled trial has shown.
Although limited to the initial clinical assessment and treatment of acute pain in the ED setting, the nonopioid prescribing strategy "could potentially help mitigate the ongoing opioid epidemic by reducing the number of people initially exposed to opioids and the subsequent risk of addiction," Andrew K. Chang, MD, from the Department of Emergency Medicine, Albany Medical College, New York, and colleagues report in an article published online November 7 in JAMA.
Between July 2015 and August 2016, 411 patients presenting to one of two urban emergency departments with acute extremity pain were randomly assigned to receive one of four analgesic regimens: 400 mg ibuprofen and 1000 mg acetaminophen, 5 mg oxycodone and 325 mg acetaminophen, 5 mg hydrocodone and 300 mg acetaminophen, or 30 mg codeine and 300 mg acetaminophen.
The study population comprised adult patients aged 21 through 64 years with acute arm or leg pain with a clinical indication for radiological imaging. By design, the need for imaging prompted a "built-in delay" that would enable the collection of 1- and 2-hour pain scores, the authors explain. Patients with chronic pain conditions requiring frequent use of analgesic medications and those with a history of methadone or narcotic use were excluded from the trial.
At 1 and 2 hours after treatment, patients' pain intensity was assessed using an 11-point numerical rating scale (NRS), where 0 is no pain and 10 is the worst possible pain. The primary endpoint was the between-group difference in mean change in NRS pain scores at 2 hours.
At baseline, pain intensity was similarly high across all four groups, with a mean NRS pain score of 8.7 (standard deviation, 1.3).
At 2 hours, pain intensity based on mean NRS score decreased by 4.3 (95% confidence interval [CI], 3.6 - 4.9) in the ibuprofen and acetaminophen group, by 4.4 (95% CI, 3.7 - 5.0) in the oxycodone and acetaminophen group, by 3.5 (95% CI, 2.9 - 4.2) in the hydrocodone and acetaminophen group, and by 3.9 (95% CI, 3.2 - 4.5) in the codeine and acetaminophen group.
"None of the differences between analgesics was statistically significant or met the a priori definition of a minimally clinically important difference in mean NRS pain score of 1.3," the authors write.
Furthermore, in a post hoc subgroup analysis restricted to those patients who rated their initial pain as a score of 10 on the NRS or who had a documented fracture on radiological imaging, "there were no statistically significant or clinically important between-group differences," the authors report.
Approximately 18% of patients included in the analysis received rescue analgesics within the 2-hour period, according to the authors. Although the distribution of the rescue painkillers between groups was not statistically significant, "the estimates varied by as much as 9% (oxycodone and acetaminophen vs codeine and acetaminophen)," they note.
Despite several limitations, including short follow-up, the use of rescue analgesia, and the lack of adverse event information, "The findings support the inference that there are no clinically meaningful differences between the analgesic effects of these 4 analgesics and suggest that a combination of ibuprofen and acetaminophen represents an alternative to oral opioid analgesics for the treatment of acute extremity pain in the ED," the authors conclude.
In an accompanying editorial, Demetrios N. Kyriacou, MD, PhD, from Northwestern University Feinberg School of Medicine in Chicago, Illinois, states that the study provides "important evidence" supporting the use of nonopioid painkillers for selected patients in the ED setting.
"The demonstrated effectiveness of the ibuprofen and acetaminophen combination for moderate to severe pain may also translate to outpatient management and other clinical settings of patients with acute pain. However, this will require future investigations," he notes.
Important and novel features of the current study, Dr Kyriacou continues, "were the use of standard doses of common medications for patients with moderate to severe pain (mean pain score of 8.7 on the 0 to 10 numerical rating scale) and the use of a standard pain score that is familiar to clinicians in the ED setting," he writes. "These aspects allow a certain degree of generalizability to other EDs and other acute medical care settings."
Although reducing overall prescribed opioids may limit nonmedical use of the drugs, "a blanket approach restricting opioid medications may adversely affect certain patients who achieve better pain reduction from opioid vs nonopioid medications," Dr Kyriacou continues.
"One strategy could be to use nonopioid treatment of moderate to severe acute pain for patients who are at greater risk for long-term opioid use. This could be especially effective if prediction models are developed to accurately identify patients at greater risk for opioid addiction based on a single prescription exposure for an episode of acute pain."
Importantly, Dr Kyriacou stresses, "[s]temming the opioid addiction crisis will also require reexamination of the long-standing assumptions that opioids are superior to nonopioids in most clinical situations requiring management of moderate to severe pain." In this regard, he concludes, "[g]enuine efforts should be made to reduce overall opioid prescribing in the ED setting while still providing adequate pain relief."
The authors and editorialists have disclosed no relevant financial relationships.
JAMA. 2017;318:1661-1667. Article abstract, Editorial extract