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Efficacy of the combination neurokinin-1 receptor antagonist, palonosetron, and dexamethasone compared to others for the prophylaxis of chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis of randomized controlled trials.
Chow, R, Tsao, M, Chiu, L, Popovic, M, Milakovic, M, Lam, H, DeAngelis, C
Annals of palliative medicine. 2018;(2):221-233
Abstract
BACKGROUND Chemotherapy-induced nausea and vomiting (CINV), a common side effect of chemotherapy, can substantially impair a patient's quality of life, interfere with a patient's compliance with anticancer therapy, and result in the manifestation of adverse events such as electrolyte imbalance, dehydration and malnutrition. The most recent guidelines published by the Multinational Association of Supportive Care in Cancer (MASCC) and European Society of Medical Oncology (ESMO) recommend the combination of dexamethasone (DEX), a 5-hydroxytrypatmine-3 receptor antagonist (5-HT3RA), preferably palonosetron (PALO), and a neurokinin-1 receptor antagonist (NK1RA) for prophylactic treatment of CINV in patients receiving highly emetogenic chemotherapy (HEC). The aim of this review was to examine the efficacy of triple agent, as reported in randomized controlled trials (RCTs), compared to any other prophylactic treatments. METHODS A literature search was conducted in Ovid MEDLINE(R), Embase Classic & Embase, and the Cochrane Central Register of Controlled Trials. The primary endpoint was the proportion of patients achieving complete response (CR) in the acute, delayed and overall phase. Secondary endpoints included the percentage of patients who achieved complete control (CC), no nausea and no vomiting in the acute, delayed and overall phases. RESULTS A total of 17 RCTs were included in this review, of which 3,146 patients were randomized to receive NK1RA, PALO and DEX, and 2,987 patients to receive other antiemetic treatments. The combination was not superior to other treatments in five endpoints-CC and CR in the acute phase, nausea and emesis control in the delayed phase, and nausea in the overall phase-but was superior in the other 11 endpoints. When looking only at HEC and moderately emetogenic chemotherapy (MEC) studies, the combination was only superior to others in three endpoints (delayed and overall CC, and overall emesis control) in HEC setting, which is less than the nine identified endpoints (delayed and overall CR, delayed and overall CC, acute and overall nausea control, and acute, delayed and overall phases for emesis control) in the MEC setting. CONCLUSIONS The combination of NK1RA, PALO and DEX is superior in the majority of assessed endpoints of this meta-analysis. Further studies should investigate the efficacy and safety of the triple regimen compared to regimens lacking NK1RA, to add to the discussions about whether future CINV prophylaxis guidelines should include NK1RA as a first-line treatment in the MEC setting.
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Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial.
Kahn, RL, Cheng, J, Gadulov, Y, Fields, KG, YaDeau, JT, Gulotta, LV
Regional anesthesia and pain medicine. 2018;(6):572-579
Abstract
BACKGROUND AND OBJECTIVES Perineural dexamethasone and intravenous (IV) dexamethasone have been shown to prolong peripheral nerve block duration. The effects of perineural and IV dexamethasone have only been compared at doses of 4 mg or greater. This triple-blind, randomized trial examined the effect of 1 mg IV versus perineural dexamethasone on interscalene block (ISB) analgesia duration. METHODS Patients undergoing ambulatory shoulder arthroscopy received an ultrasound-guided ISB with 15 mL bupivacaine 0.5% and 1 mg preservative-free dexamethasone that was administered perineurally (PeriD) or IV (IVDex). All patients received IV ketorolac and were discharged on naproxen 500 mg 2 times a day plus oxycodone/acetaminophen as needed. Peripheral nerve block duration, pain, opioid consumption, and block satisfaction were assessed via telephone follow-ups. RESULTS There were 63 PeriD patients and 62 IVDex patients who completed the primary outcome follow-up. The median time until analgesia from the ISB completely wore off was 3.5 hours (95% confidence interval, 1.0-6.0 hours) longer in the PeriD versus IVDex groups; P = 0.007). Time until the pain relief from the ISB began to wear off was also longer in the PeriD versus IVDex group (5.5 hours [95% confidence interval, 2.1-9.0 hours]; P = 0.002). Other secondary outcomes, including opioid consumption, satisfaction, and pain scores, were not different between groups. CONCLUSIONS In patients undergoing shoulder arthroscopy, low-dose perineural dexamethasone (1 mg) in combination with 15 mL of 0.5% bupivacaine prolonged the median time until pain relief from the ISB completely wore off compared with 1 mg IV dexamethasone. However, the degree of prolongation was smaller than the a priori-defined minimal clinically meaningful difference of 5 hours. CLINICAL TRIAL REGISTRATION This study was registered at Clinicaltrials.gov, identifier NCT02506660.
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Plantar Fasciitis-A Comparison of Treatment with Intralesional Steroids versus Platelet-Rich Plasma A Randomized, Blinded Study.
Acosta-Olivo, C, Elizondo-Rodriguez, J, Lopez-Cavazos, R, Vilchez-Cavazos, F, Simental-Mendia, M, Mendoza-Lemus, O
Journal of the American Podiatric Medical Association. 2017;(6):490-496
Abstract
BACKGROUND Many treatment options for plantar fasciitis currently exist, some with great success in pain relief. The objective of our study was to compare the use of intralesional steroids with platelet-rich plasma (PRP), using pain scales and functional evaluation, in patients with plantar fasciitis who did not respond to conservative treatment. METHODS A controlled, randomized, blinded clinical assay was performed. Patients were assigned to one of the two groups by selecting a sealed envelope. The steroid treatment group received 8 mg of dexamethasone plus 2 mL of lidocaine as a local anesthetic. The PRP treatment group received 3 mL of PRP activated with 0.45 mL of 10% calcium gluconate. All of the patients were evaluated at the beginning of the study, and at 2, 4, 8, 12, and 16 weeks post-treatment with the Visual Analog Scale (VAS), Foot and Ankle Disability Index (FADI), and American Orthopedic Foot and Ankle Society (AOFAS) scale. RESULTS The right foot was the most frequently affected foot (63%). The average age of the patients was 44.8 years (range, 24-61 years). All scales used (VAS, FADI and AOFAS) showed that the difference was not statistically significant between the two groups. CONCLUSIONS We can conclude that the use of PRP is an effective treatment method for patients with plantar fasciitis who do not respond to conservative treatment because PRP demonstrates an efficacy equal to that of steroids. However, the cost and the time for preparation the PRP are two of the disadvantages of this treatment.
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Oral dexamethasone decreases postoperative pain, swelling, and trismus more than diclofenac following third molar removal: a randomized controlled clinical trial.
Lima, CAA, Favarini, VT, Torres, AM, da Silva, RA, Sato, FRL
Oral and maxillofacial surgery. 2017;(3):321-326
Abstract
PURPOSE The aim of this study was to compare the anti-inflammatory potential of two pharmacotherapy protocols based on the parameters of pain, trismus, and swelling, after extraction of third molars. METHODS Thirty patients selected with symmetrical impaction of third molars were submitted to surgical procedures in both sides in different times. For one group, dexamethasone was used for 3 days, and for another group diclofenac sodium was also used for the same period. The main variables analyzed were the visual analogue pain scale (VAS), but others were also analyzed such as swelling and trismus, which were submitted to statistical analysis. RESULTS The results had no difference regarding the length of procedures (p = 0.986) and the pain in the immediate and 4-h postoperative period (p = 0.723 and 0.541). The rescue analgesic consumption was higher (p < 0.05) when using the protocol with diclofenac sodium. The variables mouth opening (p < 0.05) and swelling (p < 0.05) were significantly better when using the protocol with dexamethasone in the postoperative period. CONCLUSIONS Medical protocol with the use of dexamethasone in the postoperative period was more effective in controlling pain, trismus, and swelling, after the extraction of third molars, when compared to diclofenac sodium.
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PROSPECTIVE RANDOMIZED SUBJECT-MASKED STUDY OF INTRAVITREAL BEVACIZUMAB MONOTHERAPY VERSUS DEXAMETHASONE IMPLANT MONOTHERAPY IN THE TREATMENT OF PERSISTENT DIABETIC MACULAR EDEMA.
Shah, SU, Harless, A, Bleau, L, Maturi, RK
Retina (Philadelphia, Pa.). 2016;(10):1986-96
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Abstract
PURPOSE To compare intravitreal bevacizumab monotherapy with intravitreal dexamethasone delayed delivery system monotherapy for persistent diabetic macular edema. METHODS Single-center, randomized, subject-masked study of eyes with persistent diabetic macular edema, defined as central subfield thickness (CST) >340 μm despite ≥3 anti-vascular endothelial growth factors injections within 5 months. The intravitreal bevacizumab monotherapy (n = 23 eyes) and delayed delivery system monotherapy (n = 27 eyes) groups received treatments q1month and q3months, respectively. RESULTS Baseline best-corrected visual acuity and CST were similar in the two groups. At Month 7, the mean final best-corrected visual acuity (mean ± SD) was 65 ± 16 letters (mean Snellen visual acuity 20/50) and 64 ± 11 letters (20/50) (P = 0.619), the mean change in best-corrected visual acuity was +5.6 ± 6.1 and +5.8 ± 7.6 letters (P = 0.785), the mean final CST was 471 ± 157 and 336 ± 89 μm (P = 0.001), and the mean change in CST was -13 ± 105 and -122 ± 120 μm (P = 0.005) in the intravitreal bevacizumab monotherapy and delayed delivery system monotherapy groups, respectively. The number of injections was 7.0 ± 0.2 and 2.7 ± 0.5 (P < 0.001) in the 2 groups. CONCLUSION The two groups had similar best-corrected visual acuity gains. The delayed delivery system monotherapy group achieved a significantly greater reduction of CST compared with the intravitreal bevacizumab monotherapy group, with a q3month interval of treatment, and had no recurrent edema at any visit.
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Comparison of the anti-inflammatory effect of dexamethasone and ketorolac in the extractions of third molars.
Paiva-Oliveira, JG, Bastos, PR, Cury Pontes, ER, da Silva, JC, Delgado, JA, Oshiro-Filho, NT
Oral and maxillofacial surgery. 2016;(2):123-33
Abstract
This double-blind, split-mouth, and randomized study was aimed to compare the efficacy of dexamethasone and ketorolac tromethamine, through the evaluation of pain, edema, and limitation of mouth opening. Thirty-four individuals aged 18-26 years, having bilateral mandibular third molars, in a similar position, were selected. Two different surgical procedures were performed on the same individual by the single surgeon. For an extraction, the individual received 1 capsule of 10 mg ketorolac tromethamine 1 h before surgery and every 8 h for 2 days. For the extraction of the contralateral side, the individual received 1 capsule of 8 mg dexamethasone 1 h before surgery and 1 placebo capsule every 8 h for 2 days. Sodium metamizol, 500 mg, was given as rescue medication in postoperative. Pain was assessed by the Visual Box Scale-11 points (BS-11) at 24 h postoperative. Edema (metric measurement) and the maximum mouth opening (interincisal) were recorded in the pre-operative, 24 h, 48 h, 72 h and 7 days postoperatively. The results showed that both therapeutic treatments used were effective in the postoperative, and there were no statistically significant differences between the groups for the pain and edema variables. However, for the limitation of mouth opening, 24 h and 7 days postoperatively, the dexamethasone group had a lower limitation of mouth opening, behaving better than the ketorolac for this variable in these periods. Due also to the higher margin of safety, the use of dexamethasone as a single dose becomes a more suitable alternative for use in routine surgical extractions of third molars.
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Comparison of therapeutic effects of magnesium sulfate vs. dexamethasone/metoclopramide on alleviating acute migraine headache.
Shahrami, A, Assarzadegan, F, Hatamabadi, HR, Asgarzadeh, M, Sarehbandi, B, Asgarzadeh, S
The Journal of emergency medicine. 2015;(1):69-76
Abstract
BACKGROUND There is controversy about the efficacy of currently used treatment modalities to alleviate migraine headaches. OBJECTIVE We aimed to evaluate and compare the effects of magnesium sulfate and combined use of dexamethasone/metoclopramide on relieving acute migraine headache. METHODS We randomly divided 70 patients who had been referred to an emergency department, into two equal treatment groups with the two treatment plans, and analyzed pain severity at baseline using a numeric rating scale (NRS). We gave dexamethasone/metoclopramide to one group and magnesium sulfate to the other group, and evaluated pain severity at 20 min and at 1- and 2-h intervals after infusion. Finally, we used repeated-measure and two-way analysis of variance for intra- and inter-group evaluations of pain severity and complications, respectively. RESULTS We found no significant differences in demographic data and pain severity at baseline (8.2 vs. 8.0) between the two groups (p < 0.05). In the dexamethasone/metoclopramide group, pain severity (mean ± standard deviation) was 7.4 ± 1.4 (p = 0.36), 6.0 ± 2.4, and 2.5 ± 2.9 (p < 0.0001) at 20-min, 1-h, and 2-h intervals after treatment, respectively, with statistically significant differences between the baseline values and 1-h and 2-h interval values. Administration of magnesium sulfate was associated with decreased pain severity at the three intervals (5.2 ± 1.7, 2.3 ± 1.9, and 1.3 ± 0.66, respectively), exhibiting significant differences compared to baseline values and the corresponding time intervals in the dexamethasone/metoclopramide group (p < 0.0001). CONCLUSIONS According to the results, magnesium sulfate was a more effective and fast-acting medication compared to a combination of dexamethasone/metoclopramide for the treatment of acute migraine headaches.
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A Randomized, Double-blind, Non-inferiority Trial of Magnesium Sulphate versus Dexamethasone for Prevention of Postoperative Sore Throat after Lumbar Spinal Surgery in the Prone Position.
Park, JH, Shim, JK, Song, JW, Jang, J, Kim, JH, Kwak, YL
International journal of medical sciences. 2015;(10):797-804
Abstract
BACKGROUND Postoperative sore throat (POST) is a frequent complication of tracheal intubation, particularly after surgery in the prone position. We designed this study to validate the non-inferiority of magnesium sulphate against dexamethasone for prevention of POST after lumbar spinal surgery. METHODS One hundred and forty-six patients were randomly allocated to receive either magnesium or dexamethasone. Before anesthetic induction, the magnesium group (n = 73) received magnesium sulphate 30 mg/kg followed by 10 mg/kg/h by continuous infusion until the end of surgery. The dexamethasone group (n = 73) received dexamethasone 8 mg. The primary endpoint was the overall incidence of POST, which was assessed serially over 48 hr postoperatively. The predefined margin of non-inferiority for magnesium against dexamethasone was 15%. RESULTS Overall incidences of POST at rest (50.7% versus 49.3% in the magnesium and dexamethasone group, respectively, p = 0.869) and swallowing (65.8% versus 61.6% in the magnesium and dexamethasone group, respectively, p = 0.606) were not different between the groups. The upper limit of the 90% confidence interval, which must be lower than the predefined margin of non-inferiority to prove the non-inferiority of magnesium sulphate against dexamethasone, for at rest and swallowing were 14.97% (p = 0.0496) and 17.19% (p = 0.0854), respectively. The incidences and severities of POST and hoarseness were also not different between the groups throughout the study period. CONCLUSIONS Prophylactic magnesium sulphate appears to be non-inferior to dexamethasone for the prevention of POST at rest in patients undergoing lumbar spinal surgery in the prone position.
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Comparative analysis of preemptive analgesic effect of dexamethasone and diclofenac following third molar surgery.
Simone, JL, Jorge, WA, Horliana, AC, Canaval, TG, Tortamano, IP
Brazilian oral research. 2013;(3):266-71
Abstract
The objective of the study was to compare the analgesic effectiveness of dexamethasone and diclofenac sodium administered preemptively after surgical removal of third molars. Forty-four ASA (American Society of Anesthesiologists) I patients (19 men, 35 women; 16-28 years old) randomly and double-blindly received diclofenac sodium (50 mg) or dexamethasone (8 mg) or placebo 1 h before surgery. Intensity of pain, measured with a visual analog scale (VAS), was the variable studied at different postoperative times (1 h, 2 h, 3 h, 6 h, 8 h, 12 h, 48 h, 4 d and 7 d). The total amount of rescue medication (TARM) ingested (paracetamol) was another variable of the study. The Kruskal-Wallis statistical test was used. A p value of < .05 was adopted to reject the null hypothesis. The dexamethasone group showed lower pain intensity (p < .05) than the diclofenac sodium and placebo groups (p < .05). No difference in TARM was observed among the groups (p < .05). Preemptively administered, dexamethasone was effective in controlling postoperative pain.
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Australasian randomised trial to evaluate the role of maternal intramuscular dexamethasone versus betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability (A*STEROID): study protocol.
Crowther, CA, Harding, JE, Middleton, PF, Andersen, CC, Ashwood, P, Robinson, JS, ,
BMC pregnancy and childbirth. 2013;:104
Abstract
BACKGROUND Both dexamethasone and betamethasone, given to women at risk of preterm birth, substantially improve short-term neonatal health, increase the chance of the baby being discharged home alive, and reduce childhood neurosensory disability, remaining safe into adulthood. However, it is unclear which corticosteroid is of greater benefit to mother and child.This study aims to determine whether giving dexamethasone to women at risk of preterm birth at less than 34 weeks' gestation increases the chance of their children surviving free of neurosensory disability at two years' corrected age, compared with betamethasone. METHODS/DESIGN Design randomised, multicentre, placebo controlled trial.Inclusion criteria women at risk of preterm birth at less than 34 weeks' gestation with a singleton or twin pregnancy and no contraindications to the use of antenatal corticosteroids and who give informed consent.Trial entry & randomisation at telephone randomisation eligible women will be randomly allocated to either the dexamethasone group or the betamethasone group, allocated a study number and corresponding treatment pack.Study groups women in the dexamethasone group will be administered two syringes of 12 mg dexamethasone (dexamethasone sodium phosphate) and women in the betamethasone group will be administered two syringes of 11.4 mg betamethasone (Celestone Chronodose). Both study groups consist of intramuscular treatments 24 hours apart.Primary study outcome death or any neurosensory disability measured in children at two years' corrected age.Sample size a sample size of 1449 children is required to detect either a decrease in death or any neurosensory disability from 27.0% to 20.1% with dexamethasone compared with betamethasone, or an increase from 27.0% to 34.5% (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2). DISCUSSION This study will provide high-level evidence of direct relevance for clinical practice. If one drug clearly results in significantly fewer deaths and fewer disabled children then it should be used consistently in women at risk of preterm birth and would be of great importance to women at risk of preterm birth, their children, health services and communities. TRIAL REGISTRATION NUMBER ACTRN12608000631303.