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Use of Intravenous Acetaminophen in Children for Analgesia After Spinal Fusion Surgery: A Randomized Clinical Trial.

ABSTRACT: OBJECTIVES:Opioid pharmacotherapy is the cornerstone of postoperative analgesia. Despite its effectiveness, it has a variety of potential adverse effects. Therefore, a multimodal approach with non-opioid analgesics would be optimal. The aim of this study was to determine if intravenous (IV) acetaminophen would reduce opioid requirements and improve clinical outcomes in children after surgery. METHODS:A single-center, randomized, double-blind study was conducted in 57 children (10-18 years old) undergoing posterior spine fusion surgery between July 2011 to May 2014. All subjects received either acetaminophen or placebo at the end of surgery, followed by repeated doses every 6 hours for a total of 8 doses. RESULTS:In the first 24 postoperative hours, the average opioid consumption was lower for the active group compared with the placebo group (p = 0.02). The total unadjusted time to patient controlled analgesia (PCA) discontinuation was also longer in the placebo group than the active group (90 hours vs. 73 hours, p = 0.02); however, this was not statistically significant after normalizing for body weight. Additionally, time to first solid intake was longer without the use of acetaminophen (69 hours vs. 49 hours, p = 0.01). CONCLUSIONS:Postoperative use of IV acetaminophen was associated with earlier time to diet advancement and discontinuation of IV analgesics and may result in lower opioid consumption.

SUBMITTER: Rizkalla N

PROVIDER: S-EPMC6213625 | biostudies-literature | 2018 Sep-Oct

REPOSITORIES: biostudies-literature

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Use of Intravenous Acetaminophen in Children for Analgesia After Spinal Fusion Surgery: A Randomized Clinical Trial.

Rizkalla Nicole N Zane Nicole R NR Prodell Janice L JL Elci Okan U OU Maxwell Lynne G LG DiLiberto Mary Ann MA Zuppa Athena F AF

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG 20180901 5

<h4>Objectives</h4>Opioid pharmacotherapy is the cornerstone of postoperative analgesia. Despite its effectiveness, it has a variety of potential adverse effects. Therefore, a multimodal approach with non-opioid analgesics would be optimal. The aim of this study was to determine if intravenous (IV) acetaminophen would reduce opioid requirements and improve clinical outcomes in children after surgery.<h4>Methods</h4>A single-center, randomized, double-blind study was conducted in 57 children (10- ...[more]

PMID: 30429694

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Project description:ImportanceOpioid-induced ventilatory depression and hypoxemia is common, severe, and often unrecognized in postoperative patients. To the extent that nonopioid analgesics reduce opioid consumption, they may decrease postoperative hypoxemia.ObjectiveTo test the hypothesis that duration of hypoxemia is less in patients given intravenous acetaminophen than those given placebo.Design, setting, and participantsRandomized, placebo-controlled, double-blind trial conducted at 2 US academic hospitals among 570 patients who were undergoing abdominal surgery, enrolled from February 2015 through October 2018 and followed up until February 2019.InterventionsParticipants were randomized to receive either intravenous acetaminophen, 1 g (n = 289), or normal saline placebo (n = 291) starting at the beginning of surgery and repeated every 6 hours until 48 postoperative hours or hospital discharge, whichever occurred first.Main outcomes and measuresThe primary outcome was the total duration of hypoxemia (hemoglobin oxygen saturation [Spo2] <90%) per hour, with oxygen saturation measured continuously for 48 postoperative hours. Secondary outcomes were postoperative opioid consumption, pain (0- 10-point scale; 0: no pain; 10: the most pain imaginable), nausea and vomiting, sedation, minimal alveolar concentration of volatile anesthetic, fatigue, active time, and respiratory function.ResultsAmong 580 patients randomized (mean age, 49 years; 48% women), 570 (98%) completed the trial. The primary outcome, median duration with Spo2 of less than 90%, was 0.7 (interquartile range [IQR], 0.1-5.1) minutes per hour among patients in the acetaminophen group and 1.1 (IQR, 0.1-6.6) minutes per hour among patients in the placebo group (P = .29), with an estimated median difference of -0.04 (95% CI,-0.18 to 0.11) minutes per hour. None of the 8 secondary end points differed significantly between the acetaminophen and placebo groups. Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, -0.28; 95% CI, -0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21).Conclusions and relevanceAmong patients who underwent abdominal surgery, use of postoperative intravenous acetaminophen, compared with placebo, did not significantly reduce the duration of postoperative hypoxemia over 48 hours. The study findings do not support the use of intravenous acetaminophen for this purpose.Trial registrationClinicalTrials.gov Identifier: NCT02156154.

Project description:IntroductionThis study aimed to compare the efficacy between patient-controlled caudal epidural analgesia (PCCA) and patient-controlled intravenous analgesia (PCIA) after perianal surgery, to provide a feasible solution to postoperative pain.MethodsThis was a prospective, randomized controlled trial comprising 100 patients who underwent caudal epidural block on perianal surgery at Chengdu Shang Jin Nan Fu Hospital of West China Hospital at Sichuan University between April and August 2020. Patients were randomly divided into the PCCA and PCIA groups. Visual analog scale (VAS) scores were recorded at 2, 4, 6, 24, 48, and 72 h after surgery, and at the first dressing change and first defecation. The lower limb mobility in the post-anesthetic recovery room (PACU) was determined. The analgesic effect, usage amount of patient-controlled analgesia (PCA), usage amount and frequency of remedial analgesic measures, number of individuals who must be catheterized, and incidence of adverse reactions were recorded. Satisfaction of postoperative analgesic effect and convenience of PCA were also assessed.ResultsThe patients in the PCCA group had significantly lower VAS scores at 4, 6, 24, 48, 72 h, the first dressing change, and the first defecation compared with the PCIA group. There were more patients receiving postoperative remedial analgesics in the PCIA group than in the PCCA group. The outcome of the number of PCA and catheterization rates did not differ significantly between the groups. There were two cases of sensory numbness below the S3 plane. The major postoperative complications in the PCIA group were pruritus (3/47, 6.4%), nausea, and vomiting (6/47, 12.8%) (one case combined with pruritus). Patients in the PCCA group were more satisfied with the analgesic effect, while those in the PCIA group were more satisfied with the convenience.ConclusionIn the postoperative analgesia program of perianal surgery, PCCA may provide a better analgesic effect without increasing the incidence of complications.Trial registrationChinese Clinical Trial Registry identifier, ChiCTR2000038425, September 2020, retrospectively registered.

Project description:BackgroundThe efficacy of intravenous (IV) acetaminophen compared with its oral formulation for postoperative analgesia is unknown. We hypothesized that the addition of acetaminophen to a multimodal analgesia regimen would provide improved pain management in patients after total knee arthroplasty (TKA) and that the effect of acetaminophen would be variable based on the route of delivery.MethodsThe study was a single-center, randomized, double-blinded, placebo-controlled clinical trial on the efficacy of IV vs oral acetaminophen in patients undergoing unilateral TKA. One hundred seventy-four subjects were randomized to one of the 3 groups: IV acetaminophen group (IV group, n = 57) received 1 g IV acetaminophen and oral placebo before postanesthesia care unit (PACU) admission; oral acetaminophen group (PO group, n = 58) received 1 g oral acetaminophen and volume-matched IV normal saline; placebo group (Placebo group, n = 59) received oral placebo and volume-matched IV normal saline. Pain scores were obtained every 15 minutes during PACU stay. Average pain scores, maximum pain score, and pain scores before physical therapy were compared among the 3 groups. Secondary outcomes included total opiate consumption, time to PACU discharge, time to rescue analgesia, and time to breakthrough pain.ResultsThe average PACU pain score was similar in the IV group (0.56 ± 0.99 [mean ± standard deviation]) compared with the PO group (0.67 ± 1.20; P = .84) and Placebo group (0.58 ± 0.99; P = .71). Total opiate consumption at 6 hours (0.47 mg hydromorphone equivalents ± 0.56 vs 0.54 ± 0.53 vs 0.54 ± 0.61; P = .69) and at 24 hours (1.25 ± 1.30 vs 1.49 ± 1.34 vs 1.36 ± 1.31; P = .46) were also similar between the IV, PO, and Placebo groups. No significant differences were found between all groups for any other outcome.ConclusionNeither IV nor oral acetaminophen provides additional analgesia in the immediate postoperative period when administered as an adjunct to multimodal analgesia in patients undergoing TKA in the setting of a spinal anesthetic.

Project description:Importance: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. Objective: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. Interventions: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. Results: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. Trial Registration:clinicaltrials.gov Identifier: NCT01608308.

Project description:BACKGROUND:Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium. METHODS:This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis. DISCUSSION:This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015.

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Use of Intravenous Acetaminophen in Children for Analgesia After Spinal Fusion Surgery: A Randomized Clinical Trial.

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Use of Intravenous Acetaminophen in Children for Analgesia After Spinal Fusion Surgery: A Randomized Clinical Trial.

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