Chronic use of tramadol after acute pain episode: cohort studyBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1849 (Published 14 May 2019) Cite this as: BMJ 2019;365:l1849
- Cornelius A Thiels, assistant professor of health services research1 2,
- Elizabeth B Habermann, professor of health services research2,
- W Michael Hooten, professor of anesthesiology3,
- Molly M Jeffery, research associate and visiting fellow2 4
- 1Department of Surgery, Mayo Clinic, Rochester, MN, USA
- 2Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery and Department of Health Services Research, Mayo Clinic, Rochester, MN 55905, USA
- 3Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA
- 4OptumLabs, Cambridge, MA 02142, USA
- Correspondence to: M M Jeffery @MollyJeffery on Twitter or
- Accepted 25 March 2019
Objective To determine the risk of prolonged opioid use in patients receiving tramadol compared with other short acting opioids.
Design Observational study of administrative claims data.
Setting United States commercial and Medicare Advantage insurance claims (OptumLabs Data Warehouse) January 1, 2009 through June 30, 2018.
Participants Opioid-naive patients undergoing elective surgery.
Main outcome measure Risk of persistent opioid use after discharge for patients treated with tramadol alone compared with other short acting opioids, using three commonly used definitions of prolonged opioid use from the literature: additional opioid use (defined as at least one opioid fill 90-180 days after surgery); persistent opioid use (any span of opioid use starting in the 180 days after surgery and lasting ≥90 days); and CONSORT definition (an opioid use episode starting in the 180 days after surgery that spans ≥90 days and includes either ≥10 opioid fills or ≥120 days’ supply of opioids).
Results Of 444 764 patients who met the inclusion criteria, 357 884 filled a discharge prescription for one or more opioids associated with one of 20 included operations. The most commonly prescribed post-surgery opioid was hydrocodone (53.0% of those filling a single opioid), followed by short acting oxycodone (37.5%) and tramadol (4.0%). The unadjusted risk of prolonged opioid use after surgery was 7.1% (n=31 431) with additional opioid use, 1.0% (n=4457) with persistent opioid use, and 0.5% (n=2027) meeting the CONSORT definition. Receipt of tramadol alone was associated with a 6% increase in the risk of additional opioid use relative to people receiving other short acting opioids (incidence rate ratio 95% confidence interval 1.00 to 1.13; risk difference 0.5 percentage points; P=0.049), 47% increase in the adjusted risk of persistent opioid use (1.25 to 1.69; 0.5 percentage points; P<0.001), and 41% increase in the adjusted risk of a CONSORT chronic opioid use episode (1.08 to 1.75; 0.2 percentage points; P=0.013).
Conclusions People receiving tramadol alone after surgery had similar to somewhat higher risks of prolonged opioid use compared with those receiving other short acting opioids. Federal governing bodies should consider reclassifying tramadol, and providers should use as much caution when prescribing tramadol in the setting of acute pain as for other short acting opioids.
Contributors: CAT, EBH, WMH, and MMJ conceived and designed this work. MMJ and CAT cleaned and analyzed the data. CAT, EBH, and MMJ interpreted the data, and all authors were responsible for drafting the work and revising it critically for important intellectual content. All authors gave final approval of the version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. MMJ is the guarantor.
Funding: This study had no external funding. Support was provided by the Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Because it uses pre-existing, de-identified data, this study was determined to be exempt from review by the Mayo Clinic Institutional Review Board.
Data sharing: OptumLabs data are available for research through a virtual data warehouse. The authors are not able to distribute the data.
Transparency statement: The lead author (the manuscript’s guarantor) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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