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Can intravenous acetaminophen given at the time of sinus surgery control postoperative pain better than placebo?
In this prospective, randomized clinical trial including 62 patients undergoing endoscopic sinus surgery for chronic rhinosinusitis, intravenous acetaminophen given within the first hour after surgery was associated with a reduction in pain and this difference may be clinically meaningful.
Given our inconclusive results and the high cost of intravenous acetaminophen we cannot recommend it as a pain control regimen after sinus surgery.
Intravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results.
To compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS).
Design, Setting, and Participants
A prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital.
Participants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose.
Main Outcomes and Measures
The primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period.
Of the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (−5.2 to 16.8) and 8.2 (−1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive conclusions.
Conclusions and Relevance
The results of this study are inconclusive. The data suggest that perioperative intravenous acetaminophen may reduce immediate postoperative pain and opioid requirements compared with placebo and these differences could be clinically meaningful. Unfortunately, the imprecision of the estimates prevents definitive conclusion. Use of IVAPAP does not seem to increase adverse events.
clinicaltrials.gov Identifier: NCT01608308
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Corresponding Author: Amber Luong, MD, PhD, Department of Otorhinolaryngology–Head and Neck Surgery, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, MSB 5.036, Houston, TX 77030 (firstname.lastname@example.org).
Accepted for Publication: February 22, 2017.
Published Online: May 25, 2017. doi:10.1001/jamaoto.2017.0238
Author Contributions: Drs Luong and Tyler had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Tyler, Kain, Fakhri, Cattano, Luong.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Tyler, Lam, Ashoori, Cai, Kain, Citardi, Cattano, Luong.
Critical revision of the manuscript for important intellectual content: Tyler, Lam, Ashoori, Kain, Fakhri, Cattano, Luong.
Statistical analysis: Tyler, Cai, Cattano.
Obtained funding: Cattano, Luong.
Administrative, technical, or material support: Tyler, Lam, Ashoori, Kain, Fakhri, Citardi, Cattano.
Study supervision: Fakhri, Citardi, Cattano, Luong.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Cattano was the recipient of a research grant from Cadence Pharma, Inc, now Mallinkrodt Pharma, Inc. The Department of Otorhinolaryngology at the McGovern Medical School received industry research funding from Allakos and Intersect ENT. Dr Luong received consulting fees from 480 Biomedical, Aerin Medical, ENTvantage, Laurimed, and Medtronic. Dr Citardi received consulting fees from JNJ/Acclarent. Dr Fakhri received consulting fees from IntersectENT. The remaining authors have no financial interests to disclose.
Funding/Support: The trial was funded by Mallinkrodt Pharma.
Role of the Funder/Sponsor: Mallinkrodt Pharma had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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