People receiving only tramadol after surgery were at slightly higher risk for prolonged opioid use than those receiving other short-acting opioids, according to findings published in BMJ.
“The U.S. FDA continues to classify tramadol at a lower level than other opioids such as morphine and oxycodone, both schedule II. As a result, many studies investigating the risks of opioid use have excluded tramadol,” Cornelius Thiels, DO, from the department of surgery at Mayo Clinic, and colleagues wrote. “Data to support the reputed safety and lower dependence risk of tramadol are lacking.”
The researchers assessed the risk for transitioning from acute to prolonged use in opioid-naive patients treated with tramadol compared with other short-acting opioids for postoperative pain in an observational study using U.S. administrative claims data from 2009 to mid-2018.
Prolonged opioid use was defined as: additional use (at least one opioid fill 90 to 180 days post-surgery); persistent use (starting in the 180 days after surgery and lasting 90 or more days); and an opioid use episode that began in the 180 days after surgery that spanned 90 or more days and included either 10 or more opioid fills or 120 or more days’ supply of opioids (ie, the CONSORT definition).
Overall, 357,884 patients filled a discharge prescription for one or more opioids after surgery.
While the most commonly prescribed post-surgery opioid was hydrocodone and short-acting oxycodone (53% and 37.5%), 4% of patients (n = 16,059) were prescribed tramadol.
Thiels and colleagues observed additional use of opioids in 7.1% (n = 31,431) of the sample, persistent use of opioids in 1% (n = 4,457) of the sample and meeting the CONSORT definition in 0.5% (n = 2,027) of the sample. They found that patients who received tramadol alone were at 6% increased risk for additional opioid use compared with people receiving other short-acting opioids (95% CI, 1-1.13), at 47% increased risk for persistent opioid use (95% CI, 1.25-1.69) and at 41% increase in the adjusted risk of a CONSORT chronic opioid use episode (95% CI, 1.08-1.75).
"This data will force us to reevaluate our postsurgical prescribing guidelines," Thiels said in a press release. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."
In the full study, Thiels and colleagues wrote that the Drug Enforcement Administration and FDA should think about rescheduling tramadol, currently a schedule IV drug, to a level that better reflects its risk for prolonged use. – by Savannah Demko
Disclosure: The authors report no relevant financial disclosures.