A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement

Park, Yong Bum; Ha, Chul‐Won; Cho, Sung Do; Lee, Myung Chul; Lee, Ju Hong; Seo, Seung Suk; Kang, Sungchul; Kyung, Hee-Soo; Choi, Choong Hyeok; Chang, N.W.; Rhim, Hyou Young; Bin, Seong‐Il

doi:10.1185/03007995.2014.975338

Cited by 15 publications

(31 citation statements)

References 8 publications

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“…It is difficult to estimate the incidence of OINV as the data on OINV are generally limited. Research suggests that approximately 40% of patients may experience nausea and 15%–25% of patients may experience vomiting after opioid administration (Chang et al., ; Daniels et al., ; Kalso et al., ; Musclow, Bowers, Vo, Glube, & Nguyen, ; Park et al., ). A recent meta‐analysis of postoperative nausea and vomiting studies determined that the median incidence of postoperative nausea was 36% (95% confidence interval [CI], 18%–45%) and the median incidence of postoperative vomiting was 25% (95% CI, 16%–25.5%; Apfel et al., ).…”

Section: Introductionmentioning

confidence: 99%

The pathophysiology, incidence, impact, and treatment of opioid‐induced nausea and vomiting

Mallick-Searle

Fillman

2017

Journal of the American Association of Nurse Practitioners

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Purpose Opioid medications are integral in managing acute moderate‐to‐severe pain. Opioid analgesics bind to μ (mu), κ (kappa), or δ (delta) opioid receptors in the brain, spinal cord, and digestive tract. However, opioids cause adverse effects that may interfere with their therapeutic use. Some adverse effects wane over time, but patients using opioids for acute pain struggle with opioid‐induced nausea and vomiting (OINV) the entire time they take the opioid. This article discusses the underlying mechanisms, clinical implications, and treatment strategies of OINV. Data sources Systematic search and review of Medline, PubMed, and Google Scholar for articles relating to OINV. In addition, package inserts provided pharmacologic data and dose recommendations as needed. Conclusions Research suggests approximately 40% of patients may experience nausea and 15%–25% of patients may experience vomiting after opioid administration. Nausea often precedes vomiting, although they can occur separately. Many patients receiving opioids rate the nausea and vomiting as worse than their pain. Nausea and vomiting can lead to complications including electrolyte imbalances, malnutrition, and volume depletion, and can also negatively affect quality of life and postoperative recovery. Implications for practice There are several medications that can be used to treat OINV including serotonin receptor antagonists, dopamine receptor antagonists, and neurokinin‐1 receptor antagonists. Healthcare providers should be proactive about discussing OINV with patients, as this may improve patient outcomes and pain relief.

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Section: Introductionmentioning

confidence: 99%

The pathophysiology, incidence, impact, and treatment of opioid‐induced nausea and vomiting

Mallick-Searle

Fillman

2017

Journal of the American Association of Nurse Practitioners

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“…All three studies reported no difference in the incidence of opioid-related adverse events between patients given modified-release or immediaterelease opioids after surgery (Table 1) [29,31,35]. [29][30][31][32]36], and physical function in one trial [29].…”

Section: Resultsmentioning

confidence: 99%

“…One study was removed from the meta-analysis of efficacy outcomes [30] and one was removed from the safety outcomes [31] due to significant methodological heterogeneity in the pain intensity and adverse event outcomes reported, respectively. The mean (SD) values reported in the study by Park et al were reversed between modified-release and immediate-release groups to account for the direction of effect [32]. A random effects model with inverse variance was used for all meta-analyses [33].…”

Section: Methodsmentioning

confidence: 99%

Risks and benefits of oral modified‐release compared with oral immediate‐release opioid use after surgery: a systematic review and meta‐analysis

et al. 2023

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SummaryPrescription of modified‐release opioids for acute postoperative pain is widespread despite evidence to show their use may be associated with an increased risk of adverse effects. This systematic review and meta‐analysis aimed to examine the available evidence on the safety and efficacy of modified‐release, compared with immediate‐release, oral opioids for postoperative pain in adults. We searched five electronic databases from 1 January 2003 to 1 January 2023. Published randomised clinical trials and observational studies on adults who underwent surgery which compared those who received oral modified‐release opioids postoperatively with those receiving oral immediate‐release opioids were included. Two reviewers independently extracted data on the primary outcomes of safety (incidence of adverse events) and efficacy (pain intensity, analgesic and opioid use, and physical function) and secondary outcomes (length of hospital stay, hospital readmission, psychological function, costs, and quality of life) up to 12 months postoperatively. Of the eight articles included, five were randomised clinical trials and three were observational studies. The overall quality of evidence was low. Modified‐release opioid use was associated with a higher incidence of adverse events (n = 645, odds ratio (95%CI) 2.76 (1.52–5.04)) and worse pain (n = 550, standardised mean difference (95%CI) 0.2 (0.04–0.37)) compared with immediate‐release opioid use following surgery. Our narrative synthesis concluded that modified‐release opioids showed no superiority over immediate‐release opioids for analgesic consumption, length of hospital stay, hospital readmissions or physical function after surgery. One study showed that modified‐release opioid use is associated with higher rates of persistent postoperative opioid use compared with immediate‐release opioid use. None of the included studies reported on psychological function, costs or quality of life.

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“…The primary outcome variables were maximum and mean pain intensity scores (VAS every 6 h for 24 h) comparing the acetaminophen/ibuprofen group and the ketorolac (active comparator/control) group [15,16]. The mean pain intensity and mean nausea scores were the scores present at exactly 6, 12, 18, and 24 h, while the maximum pain intensity and maximum nausea scores were the maximum score present during the entire interval from 0-6 h, 6-12 h, 12-18 h, and 18-24 h. The secondary outcomes were post-procedure opioid consumption (in morphine equivalents), mean and maximum nausea scores (VAS every 6 h for 24 h), and ondansetron consumption.…”

Section: Data Collection and Outcome Variablesmentioning

confidence: 99%

Reducing Post Procedural Pain and Opioid Consumption Using IV Acetaminophen and IV Ibuprofen Following Uterine Fibroid Embolization: A Prospective, Doubleblind, Randomized Controlled Study

Hoffman¹,

Jahr²,

Yarosh³

et al. 2018

J Imaging Interv Radiol

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Purpose: Uterine fibroid embolization (UFE) is associated with post-procedural pain and nausea. In this double-blind randomized controlled study, we compared pre-procedure intravenous (IV) acetaminophen/ibuprofen to postprocedure IV ketorolac in UFE patients. Methods:After institutional review board approval, UFE candidates 21-60 years old were screened and randomly assigned to one of four arms: acetaminophen (1 g), ibuprofen (800 mg), acetaminophen (1 g) and ibuprofen (800 mg) combined, and an active comparator, ketorolac (30 mg). All received rescue patient-controlled hydromorphone for 24 h post-procedure. Primary outcome was measurement of pain intensity (visual analog scale: VAS) between the acetaminophen/ibuprofen group and the ketorolac group. The secondary outcomes were opioid and anti-emetic requirements and nausea intensity (VAS).Results: 40 subjects were analysed: acetaminophen/ ibuprofen (N=16); acetaminophen (N=4); ibuprofen (N=4); ketorolac (N=16). The maximum and mean VAS scores for pain were not different between the acetaminophen/ ibuprofen group and the ketorolac group without adjusting for opioid consumption (p=0. 243 and p=0.208, respectively). Total opioid consumption in morphine equivalents (mean [±SE]) was 28.09 mg (±4.58) in the acetaminophen/ibuprofen group and 40.33 mg (±7.79) in the ketorolac group (p=0.087), demonstrating a trend favouring the acetaminophen/ibuprofen group. The mean and maximum nausea scores showed a trend and significant difference (p=0.095 and p=0.003), respectively, favouring the ketorolac group. Conclusion:IV acetaminophen/ibuprofen demonstrated comparable pain control, although there was less opioid requirement for the acetaminophen/ibuprofen group compared to the ketorolac group. Maximum nausea scores were significantly increased with similar ondansetron requirements. Therefore, antiemetic prophylaxis is needed regardless of group.

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A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement

Abstract: Clinicaltrials.gov, NCT01814878.

Cited by 15 publications

References 8 publications

The pathophysiology, incidence, impact, and treatment of opioid‐induced nausea and vomiting

The pathophysiology, incidence, impact, and treatment of opioid‐induced nausea and vomiting

Risks and benefits of oral modified‐release compared with oral immediate‐release opioid use after surgery: a systematic review and meta‐analysis

Reducing Post Procedural Pain and Opioid Consumption Using IV Acetaminophen and IV Ibuprofen Following Uterine Fibroid Embolization: A Prospective, Doubleblind, Randomized Controlled Study

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