Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery: A Randomized Clinical Trial

Abstract

Importance: The opioid epidemic has generated interest in optimizing opioid prescribing after common surgeries. Recent studies have shown a broad range of analgesic prescription patterns following endoscopic sinus surgery (ESS).

Objective: To compare the efficacy of different analgesic regimens after ESS.

Design, setting, and participants: This multi-institutional, nonblinded randomized clinical trial was conducted at 6 tertiary centers across the US and Canada and included participants who underwent ESS for acute or chronic rhinosinusitis. The study was conducted from March 2019 to March 2020, and the data were analyzed in November to December 2020.

Interventions: All participants received acetaminophen, 650 mg, as the first-line analgesic. From there, patients were randomized to either oxycodone rescue (oxycodone, 5 mg, as second-line therapy) or ibuprofen rescue (ibuprofen, 600 mg, as second-line therapy, with oxycodone, 5 mg, reserved for breakthrough pain).

Main outcomes and measures: Baseline characteristics and disease severity were collected at enrollment. Medication logs, pain scores, and epistaxis measures were collected until postoperative day 7. The primary outcome was the postoperative visual analog scale score for pain. Brief Pain Inventory Pain Severity and Pain Interference Scores were also collected.

Results: A total of 118 patients were randomized (62 [52.5%] oxycodone rescue, 56 [47.5%] ibuprofen rescue; mean [SD] age, 46.7 [16.3] years; 44 women [44.0%]; 83 White [83.0%], 7 Black [7.0%], and 7 Asian individuals [7.0%]). After exclusions for loss to follow-up and noncompliance, 51 remained in the oxycodone rescue group and 49 in the ibuprofen rescue group. The groups had similar demographic characteristics and disease severity. Thirty-two (63%) in the oxycodone rescue group had adequate pain management with acetaminophen only, while 19 (37%) consumed at least 1 oxycodone dose. In the ibuprofen rescue group, 18 (16%) required only acetaminophen, 28 (57%) used only acetaminophen and ibuprofen, and the remaining 13 (26%) consumed 1 or more oxycodone doses. The groups had similar average acetaminophen (9.69 vs 7.96 doses; difference, 1.73; 95% CI, -1.37 to 4.83) and oxycodone (1.89 vs 0.77 doses; difference, 1.13; 95% CI, -0.11 to 2.36) use. Both groups had similar postoperative visual analog scale scores. A subanalysis that compared opioids users with nonusers showed clinically significant lower pain scores in nonusers at multiple postoperative points.

Conclusions and relevance: In this randomized clinical trial, most patients who underwent ESS could be treated postoperatively using a nonopioid regimen of either acetaminophen alone or acetaminophen and ibuprofen. Ibuprofen as a second-line therapy did not reduce overall narcotic consumption, but the overall narcotic use was low in both groups.

Trial registration: ClinicalTrials.gov Identifier: NCT03783702.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Choby reported personal fees from Tissium and Intersect ENT outside the submitted work. Dr Akbar reported personal fees from Medtronic and Optinose and grants from Astra Zeneca outside the submitted work. Dr Nayak reported consulting fees from Medtronic, Olympus America, and Cook Medical outside the submitted work. Dr Patel reported personal fees from Medtronic, Optinose, and Regeneration Sanofi outside the submitted work. Dr Hwang reported personal fees from Lyra Therapeutics and Sanofi Regeneron outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Visual Analog Scale for Pain

Daily postoperative visual analog scale scores for participants in the oxycodone rescue and ibuprofen rescue groups. There were no statistically significant differences in postoperative daily pain scores. The numeric values at the bottom of the figure represent the difference in the means (95% CI), and the error bars on the figure reflect the 95% CI. POD indicates postoperative day.

Figure 2.. Brief Pain Inventory (BPI) Severity Score

Daily postoperative BPI severity scores for both groups. The analysis showed similar daily postoperative scores despite different medication regimens. The numeric values at the bottom of the figure represent the difference in the means (95% CI), and the error bars on the figure reflect the 95% CI. POD indicates postoperative day.

Figure 3.. Brief Pain Inventory (BPI) Interference Score

Daily postoperative BPI interference scores for subjects in the oxycodone rescue and ibuprofen rescue groups. Both groups showed similar BPI interference scores across all points. The numeric values at the bottom of the figure represent the difference in the means (95% CI), and the error bars on the figure reflect the 95% CI. POD indicates postoperative day.

Figure 4.. Subanalysis Comparing Daily Visual Analog Scale (VAS) Scores of Opioid Users and Nonusers

Daily postoperative VAS scores for opioid users and nonusers. Participants who used opioid rescue dosing had consistently higher pain scores than nonusers. The numeric values at the bottom of the figure represent the difference in the means (95% CI), and the error bars on the figure reflect the 95% CI. POD indicates postoperative day.