Intravenous Acetaminophen for Pain after Major Orthopedic Surgery: An Expanded Analysis.
Summary of "Intravenous Acetaminophen for Pain after Major Orthopedic Surgery: An Expanded Analysis."
Background and Methods:â€‚ From the time that Sinatra etÂ al. (Anesthesiology. 2005;102:822) was published to FDA apaproval of intravenous (IV) acetaminophen, an expanded analysis of the original raw study data became necessary for the regulatory submission. The following analyses were conducted: (1) sum of pain intensity differences over 24â€ƒhours (SPID24) using currently accepted imputation methods to account for both missing data and the effects of rescue; (2) efficacy results after the first 6â€ƒhours; (3) effects of gender, race/ethnicity, age, weight, surgical site, ASA Class, and serotonin antagonists; and (4) a stepwise regression analysis of why adverse events of nausea and vomiting were numerically (although not statistically) higher in the IV acetaminophen group compared with placebo. Results:â€‚ Sum of pain intensity differences over 24â€ƒhours using a 0- to 100-mm visual analog scale was statistically significantly (Pâ€ƒ<â€ƒ0.001) in favor of IV acetaminophen (nâ€ƒ=â€ƒ49) compared with placebo (nâ€ƒ=â€ƒ52). Time to rescue was found to be 3.9 and 2.1â€ƒhours, respectively, for total hip and knee arthroplasty compared with 0.8â€ƒhours for the placebo group. Rescue medication consumption, requests, and actual administration were all significantly lower in the IV acetaminophen group compared with placebo for each dosing interval, except in the 6- to 12-hours interval where a numerical trend was observed. Analysis of various subset variables demonstrated similar efficacy for each variable. A stepwise regression analysis demonstrated that AE reports of nausea and vomiting were most likely due to prerandomization events, particularly opioid consumption and presence of nausea prior to randomization. Conclusion:â€‚ Repeated-dose 24-hours end points were found to be as robust as previously published results. IV acetaminophen efficacy and safety appeared to be unaffected by specific subset variables.â–ª
Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, U.S.A. Department of Anesthesiology, David Geffen School of Medicine at UCLA, Ronald Reagan UCLA Medical Center, Los Angeles, California, U.S.A.
This article was published in the following journal.
Name: Pain practice : the official journal of World Institute of Pain
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22008309
- DOI: http://dx.doi.org/10.1111/j.1533-2500.2011.00514.x
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Medical and Biotech [MESH] Definitions
Nonexpendable items used in the performance of orthopedic surgery and related therapy. They are differentiated from ORTHOTIC DEVICES, apparatus used to prevent or correct deformities in patients.
Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.
A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.
Pain during the period after surgery.
Devices which are used in the treatment of orthopedic injuries and diseases.