Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery.
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ABSTRACT: Objective
A Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.Methods
In this post hoc subgroup analysis of orthopedic surgery subjects, 379 subjects received meloxicam IV 30 mg or IV-administered placebo every 24 hrs for ≤7 doses. Safety was assessed via AEs, laboratory tests, vital signs, and ECG, with an emphasis on specific AEs, including injection site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound healing events. Daily opioid consumption was assessed during treatment.Results
Among meloxicam IV-treated subjects, 64.7% experienced ≥1 AE versus 68.8% of placebo-treated subjects. Investigators assessed most AEs to be mild or moderate in intensity and unrelated to treatment. Total opioid consumption (36.8 mg versus 50.3 mg IV morphine equivalent dose; P=0.0081) and opioid consumption during time points 0‒24, 24‒48, 0‒48, and 0‒72 hrs were statistically significantly lower in the meloxicam IV group.Conclusion
Meloxicam IV demonstrated no significant differences in the number and frequency of AEs versus placebo in subjects following orthopedic surgery. Opioid consumption was reduced in the meloxicam IV group versus placebo.Trial registration
ClinicalTrials.gov (Identifier: NCT02720692).
SUBMITTER: Sharpe KP
PROVIDER: S-EPMC6982445 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
Publications
Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery.
Sharpe Kipling P KP Berkowitz Richard R Tyndall William A WA Boyer David D McCallum Stewart W SW Mack Randall J RJ Du Wei W
Journal of pain research 20200121
<h4>Objective</h4>A Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.<h4>Methods</h4>In this post hoc subgroup analysis of orthopedic surgery subjects, 379 subject ...[more]
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Project description:BackgroundThe opioid epidemic is one of the biggest public health crises of our time, and overprescribing of opioids after surgery has the potential to lead to long-term use. The purpose of this review was to identify and summarize the available evidence on interventions aimed at reducing opioid use after orthopedic surgery.MethodsWe searched CENTRAL, Embase and Medline from inception until August 2019 for studies comparing interventions aimed at reducing opioid use after orthopedic surgery to a control group. We recorded demographic data and data on intervention success, and recorded or calculated percent opioid reduction compared to control.ResultsWe included 141 studies (20 963 patients) in the review, of which 113 (80.1%) were randomized controlled trials (RCTs), 6 (4.3%) were prospective cohort studies, 16 (11.4%) were retrospective cohort studies, 5 (3.6%) were case reports, and 1 (0.7%) was a case series. The majority of studies (95 [67.4%]) had a follow-up duration of 2 days or less. Interventions included the use of local anesthetics and/or nerve blocks (42 studies [29.8%]), nonsteroidal anti-inflammatory drugs (31 [22.0%]), neuropathic pain medications (9 [6.4%]) and multimodal analgesic combinations (25 [17.7%]. In 127 studies (90.1%), a significant decrease in postoperative opioid consumption compared to the control intervention was reported; the median opioid reduction in these studies was 39.7% (range 5%-100%). Despite these reductions in opioid use, the effect on pain scores and on incidence of adverse effects was inconsistent.ConclusionThere is a large body of evidence from randomized trials showing the promise of a variety of interventions for reducing opioid use after orthopedic surgery. Rigorously designed RCTs are needed to determine the ideal interventions or combination of interventions for reducing opioid use, for the good of patients, medicine and society.
| S-EPMC9592092 | biostudies-literature
Project description:ObjectiveTo assess the association between preoperative opioid exposure and readmissions following common surgery.Summary background dataPreoperative opioid use is common, but its effect on opioid-related, pain-related, respiratory-related, and all-cause readmissions following surgery is unknown.MethodsWe analyzed claims data from a 20% national Medicare sample of patients ages ≥ 65 with Medicare Part D claims undergoing surgery between January 1, 2009 and November 30, 2016. We grouped patients by the dose, duration, recency, and continuity of preoperative opioid prescription fills. We used logistic regression to examine the association between prior opioid exposure and 30-day readmissions, adjusted for patient risk factors and procedure type.ResultsOf 373,991 patients, 168,579 (45%) filled a preoperative opioid prescription within 12 months of surgery, ranging from minimal to chronic high use. Preoperative opioid exposure was associated with higher rate of opioid-related readmissions, compared with naive patients [low: aOR=1.63, 95% CI=1.26-2.12; high: aOR=3.70, 95% CI=2.71-5.04]. Preoperative opioid exposure was also associated with higher risk of pain-related readmissions [low: aOR=1.27, 95% CI=1.23-1.32; high: aOR=1.62, 95% CI=1.53-1.71] and respiratory-related readmissions [low: aOR=1.10, 95% CI=1.05-1.16; high: aOR=1.44, 95% CI=1.34-1.55]. Low, moderate, and high chronic preoperative opioid exposures were predictive of all-cause readmissions (low: OR 1.09, 95% CI: 1.06-1.12); high: OR 1.23, 95% CI: 1.18-1.29).ConclusionsHigher levels of preoperative opioid exposure are associated with increased risk of readmissions after surgery. These findings emphasize the importance of screening patients for preoperative opioid exposure and creating risk mitigation strategies for patients.
| S-EPMC7935087 | biostudies-literature
Project description:BackgroundProspective collection of patient-reported opioid consumption and pain levels post-surgically may hold value in highlighting solutions related to the opioid crisis. Traditional methods for collecting patient-reported outcomes after surgery, such as paper surveys, often have poor response rates, and electronic messaging may offer more convenience and therefore yield more robust data.Questions/purposesThe purpose of this study was to evaluate whether a novel mobile phone short message service (SMS) platform would lead to better patient response rates to surveys on pain and opioid use than data-collection tools.MethodsAn SMS text messaging platform was created and implemented between September 2017 and May 2018 at an orthopedic specialty hospital. The purpose was to collect reports on opioid consumption and pain levels twice a day for 6 weeks post-surgery from patients who had undergone total hip or knee arthroplasty or a single-level lumbar microdiscectomy or decompression spine surgery. Patients who responded to fewer than 50% of the text messages were excluded.ResultsOur mobile phone text messaging platform was used by 183 patients, demonstrating a significantly higher response rate (96.1%) than our institution's post-operative email registry capture, as well as the majority of published response rates for post-operative outcomes captured through electronic and traditional data-collection systems. Response rate remained consistently high among the various surgeons and across patients, regardless of age.ConclusionsThis application of a widely available technology can improve the measurement of post-operative patient-reported outcomes. Such data can in turn be used in the development of strategies to reduce post-operative opioid use. The adoption of novel technologies at a patient level will play a key role in combating the opioid epidemic.
| S-EPMC6384206 | biostudies-literature
Project description:An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily. Safety was evaluated via adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption. The incidence of adverse events was similar between meloxicam IV- and placebo-treated subjects (63.0% versus 65.0%). Investigators assessed most adverse events as mild or moderate in intensity and unrelated to treatment. Adverse events of interest (injection-site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound-healing events) were similar between groups. Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo-treated subjects. The results suggest that meloxicam IV had a safety profile similar to that of placebo with respect to numbers and frequencies of adverse events and reduced opioid consumption in subjects with moderate to severe postoperative pain following major elective surgery.
| S-EPMC6899482 | biostudies-literature
Project description:BackgroundOpioid use after bariatric surgery is not clearly understood. Few guidelines exist to inform opioid-prescribing practices after bariatric surgery.ObjectiveTo understand opioid use following bariatric surgery.SettingUniversity hospital.MethodsBariatric surgery patients at a single center were prospectively surveyed at the time of their post-operative visit (January-May 2018). Patients were asked about their opioid use following surgery, whether they received education about opioid use and what they did with leftover medications. Demographic and operative details were obtained from the medical record.ResultsAmong 33 patients, the majority (n = 29, 88%) were female with a median age of 40 (20-68) and body mass index of 44.8 (33-78.5). Most patients had leftover narcotics (n = 25, 73%). The median number of pills used was 15 (0-48). Only 12 patients (36%) thought that they had been prescribed "too much" pain medication. Most patients reported receiving education about expectations for post-operative pain (n = 22, 69%); few recalled education about reducing or stopping opioids (n = 13, 40%). More than half of patients (n = 17, 53%) kept their leftover opioids rather than disposing of them or bringing them to an approved turn in location.ConclusionsDespite most patients having leftover opioids following surgery, few patients recognized possible overprescription. Education regarding opioid use following surgery is inconsistent, potentially contributing to the amount of retained opioids currently available. Future guidelines should focus on determining the appropriate amount of opioids to be prescribed following surgery and standardizing and improving education given to patients.
| S-EPMC8912948 | biostudies-literature
Project description:ObjectiveInappropriate opioid prescribing after surgery contributes to opioid use disorder and risk of opioid overdose. In this cross-sectional analysis of orthopedic surgical patients, we examined the role of patient location on postoperative pain intensity and opioids prescribed on hospital discharge.MethodsWe used geospatial analyses to characterize spatial patterns of mean pain intensity on the day of discharge (PiDoD) and opioid units prescribed on the day of discharge (OuPoD), as well as the effect of regional social deprivation on these outcomes.ResultsAt a 500-km radius from the surgery site, the Global Moran's I for PiDoD (2.71 × 10-3, variance = 1.67 × 10-6, P = 0.012) and OuPoD (2.19 × 10-3, SD = 1.87, variance = 1.66 × 10-6, P = 0.03) suggested significant spatial autocorrelation within each outcome. Local indicators of spatial autocorrelation, including local Moran's I, Local Indicator of Spatial Autocorrelation cluster maps, and Getis-Ord Gi* statistics, further demonstrated significant, specific regions of clustering both OuPoD and PiDoD. These spatial patterns were associated with spatial regions of area deprivation.ConclusionsOur results suggest that the outcomes of pain intensity and opioid doses prescribed exhibit varying degrees of clustering of patient locations of residence, at both global and local levels. This indicates that a given patient's pain intensity on discharge is related to the pain intensity of nearby individuals. Similar interpretations exist for OuPoD, although the relative locations of hot spots of opioids dispensed in a geographic area appear to differ from those of hot spots of pain intensity on discharge.
| S-EPMC7530566 | biostudies-literature
Project description:IntroductionOpioid-based analgesic therapy represents a cornerstone of pain management after surgery. The recent rise in opioid sales and opioid overdoses suggests it is important to maximize the safety of opioid prescribing after surgery. Given that patients may live with other family members in the home, safe storage and appropriate disposal of excess opioids after hospital discharge are necessary to prevent unintended secondary exposures. Identifying characteristics of patients who are likely to be prescribed excess opioids after surgery may enable more targeted prescription practices and safety interventions. Our study aimed to elucidate patient-reported opioid use patterns and modes of home storage of opioids among patients discharged home after Cesarean section (C-section) and thoracic surgery. Specifically, we sought to identify characteristics of patients who reported using about half or more versus less of the opioids prescribed to them for use after hospital discharge.MethodsFor this cohort study, we developed a survey on quality of analgesia following hospital discharge, amounts of opioids taken relative to the amount prescribed, reasons for not taking all prescribed medications, and storage and disposal methods for leftover opioids. Adult patients, who had C-section or thoracic surgery at a tertiary academic medical center, were given a web-based self-administered survey after discharge. Descriptive statistics (means and standard deviations, proportions) were used to describe the study sample and survey results. Comparisons between patients who reported taking about half or more versus less of the opioids prescribed to them for use after hospital discharge were made using unpaired t-tests, Mann-Whitney tests, and Chi-square tests as appropriate.ResultsThe majority (53%) of respondents after C-section (N = 30) reported taking either no or very few (less than 5) prescribed opioid pills; 83% reported taking half or less; and 17% of women, reported taking all or nearly all (5 or fewer pills left over) of their opioid prescription. In a cohort of patients after thoracic surgery (n = 31) 45% reported taking either no or very few (5 or less) prescribed opioid pills; 71% reported taking half or less; and 29% of patients reported taking all or nearly all (5 or fewer pills left over) of their opioid prescription. In both cohorts, use of opioids while hospitalized was higher in the group reporting using about half or more of prescribed opioids after discharge. Leftover opioids were stored in an unlocked location in 77% and 73% of cases following C-section and thoracic surgery, respectively.ConclusionOur findings from surveys in two distinct patient populations at a single academic medical center suggest that current opioid prescribing practices for pain management at hospital discharge following Cesarean section and thoracic surgery may not account for individual patients' analgesic requirements. Excess opioid pills are commonly stored in unsecured locations and represent a potential source for non-medical opioid use and associated morbidity and mortality in patients and their families. Research to develop goal-directed and patient-centered post-discharge opioid prescription practices and encourage opioid safety practices after surgery is needed.
| S-EPMC4732746 | biostudies-literature
Project description:Objective(s)To characterize for the first time the side effect profile, safety, and tolerability of hormonal contraception among women receiving opioid-agonist therapy.Study designWe conducted a secondary analysis of data collected from participants in a three-arm randomized controlled trial (N = 138) aimed at increasing effective contraceptive use among women receiving opioid-agonist therapy. Participants in the 2 intervention conditions (n = 90) had free access to hormonal contraception at each of the 14 visits scheduled during the 6-month intervention. Contraceptive use and side effects were recorded at each visit; participants could change methods or discontinue use at any time. Verbatim side effects were classified using Medical Dictionary for Regulatory Activities (MedDRA) terminology.ResultsOf 67 participants reporting hormonal contraceptive use, 29 (43%) initiated implants, 14 (21%) intrauterine devices, 13 (19%) combined pills, 11 (16%) progestin-only pills, 10 (15%) injectables, 1 (2%) ring, and 1 (2%) patch; the average (±standard deviation) duration of use was 129 ± 55, 129 ± 60, 108 ± 62, 102 ± 61, 111 ± 31, 145, and 18 days, respectively. A total of 321 side effects were reported by 55 (82%) participants. Fifty (75%) participants reported menstrual cycle changes/uterine bleeding, followed by headaches (16, 24%), weight gain (15, 22%), and abdominal pain or nausea/vomiting (11, 16%). No serious side effects were reported. Twelve participants (18%) changed methods and 13 (19%) discontinued all hormonal contraceptive use.Conclusion(s)The hormonal contraceptive side effects reported by this small group of women receiving opioid-agonist therapy appear consistent with those reported by the general population, was generally well-tolerated, and did not raise safety concerns.ImplicationsThese results provide important preliminary evidence that hormonal contraceptive use produces a familiar side effect profile and is well-tolerated by women receiving opioid-agonist therapy, although studies with larger samples followed over longer periods of time with appropriate comparison conditions are needed to fully assess tolerability and safety.
| S-EPMC9317667 | biostudies-literature
Project description:BackgroundWhile there is much evidence about pain management for orthopedic patients in the immediate perioperative setting, little is known about how opioids are used during inpatient rehabilitation, particularly in older adults. A safe upper limit of 50 mg oral morphine equivalents (OME) is frequently cited in guidelines.AimThe aim of this study was to characterize the dosing of opioids in an older adult population undergoing inpatient orthopedic rehabilitation (IOR).DesignRetrospective observational study.SettingInpatient units at an academic rehabilitation hospital in Toronto, Canada.PopulationAll adults aged ≥50 years old admitted for orthopedic rehabilitation between November 2019 and June 2021 following acute care admissions for either a surgical or non-surgical orthopedic indication.MethodsParticipants were divided into groups of prior opioids users, new opioids users, and opioid non-users during IOR. Demographic, clinical, and medication administration data were collected through the electronic health record and manual chart review. Average daily opioid dose for the first seven days of each stay was characterized using OME. Linear regression was used to assess for variables independently associated with opioid dose.ResultsA total of 643 patients undergoing orthopedic rehabilitation were included: 125 (19.4%) were prior opioid users, 416 (64.7%) were new opioid users, and 102 (15.9%) were non-users, with median age respectively of 72, 79, and 83. Median daily OME over the first week for prior users was 30.3 and for new users was 6.9. Opioid dose was inversely associated with age and admission for a non-surgical indication; it was positively associated with reported pain (as defined by day 3 pain score) and admission for knee replacement.ConclusionsOpioids are frequently but heterogeneously used in older adults undergoing IOR. Median OME use in this cohort of older adults was substantially lower than the 50 OME threshold suggested in guidelines, particularly for new opioid users.Clinical rehabilitation impactOlder adults require much lower opioid doses than younger patients. Pain management in older orthopedic rehabilitation inpatients is distinct from the perioperative setting and deserves tailored guidance, with a focus on using the lowest effective dose.
| S-EPMC10170320 | biostudies-literature
Project description:BackgroundAlthough new persistent opioid use and high-risk prescribing have been recognized as important postoperative complications among younger patients (18-64 years of age), little is known about the incidence for postoperative opioid use among older patients (>65 years of age).MethodsWe analyzed a 20% national sample of Medicare Part D claims among beneficiaries >65 years of age who underwent a major or minor surgical procedure between January 1, 2009, and June 30, 2015. We identified patients without an opioid prescription fill in the year before surgery and examined their perioperative and 6-month postoperative opioid prescription fills to examine the incidence of new persistent opioid use and high-risk prescribing.ResultsWe identified 81,839 opioid naïve patients who underwent surgery and filled an opioid prescription perioperatively. Overall, 9.8% developed new persistent opioid use. Risk factors for new persistent opioid use included major surgery (adjusted odds ratio [aOR] 1.24, 95% confidence interval [CI] 1.17-1.31), more comorbid conditions (aOR 1.71, 95% CI 1.58-1.84), mood disorders (aOR 1.16, 95% CI 1.09-1.24), suicide or self-harm (aOR 1.60, 95% CI 1.05-2.44), substance abuse disorders (aOR 1.38, 95% CI 1.20-1.59), filling an opioid prescription before surgery (aOR 1.67, 95% CI 1.58-1.77), higher amounts of opioids filled (aOR 1.44, 95% CI 1.37-1.52), black race (aOR 1.23, 95% CI 1.12-1.36), and Medicaid eligibility (aOR 1.45, 95% CI 1.35-1.55).ConclusionAbout 10% of Medicare beneficiaries who were previously opioid naïve continue to fill opioids past 3 months after surgery. In addition to comorbidities and mental health conditions, new persistent opioid use is associated with surgery type, preoperative opioid fill, high-risk prescribing practices, and sociodemographic factors.
| S-EPMC7216555 | biostudies-literature