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Electroporation technique for joint pain - Pilot feasibility study on TMD patients.
Tartaglia, GM, Gizdulich, A, Farronato, M, Gupta, RJ, Connelly, ST
Clinical and experimental dental research. 2020;(6):642-649
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Abstract
OBJECTIVE(S): It is well appreciated that traditional analgesic delivery routes used to treat pain associated with temporomandibular disorder (TMD) often have harmful unintended side effects as a consequence of systemic distribution. Further, localized delivery of analgesic medication via intra-articular injections involves a different set of issues limiting their clinical viability. As an option, transdermal analgesic delivery provides for prolonged pain relief and flexibility in dose administration, while limiting systemic exposure and minimizing adverse events. Incorporation of a novel electroporation technique may further increase transdermal drug penetration into synovial tissue/fluid and enhance pain reduction. The present feasibility study compares the effectiveness of an electroporation-enhanced transdermal application of diclofenac sodium to a conventional intra-articular injection of triamcinolone acetonide suspension (corticosteroids) to treat patients with TMD associated pain. METHODS Pre- and post-treatment maximal incisal mouth opening (MIO), pain visual analog scale (VAS) and surface electromyography (EMG) of 22 patients treated with electroporation-enhanced diclofenac and 37 patients treated with corticosteroids injections were collected and analyzed. RESULTS In general, patients treated with electroporation exhibited better results in terms of pain improvement (corrected p-value = .01) compared to the standard treatment, but both methods were similarly effective for improvement of MIO (corrected p-value = .71) and improvement of all EMG indices (corrected p-values ≥ .05). CONCLUSION The enhancing effect of electroporation in transdermal delivery of diclofenac sodium was demonstrated by decreased pain, increase MIO and EMG improvement to normal values. Its analgesic and inflammatory results are comparable with standard treatment offered by corticosteroids.
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Cardiovascular safety of hydroxypropyl-β-cyclodextrin-diclofenac in the management of acute postsurgical pain: a pooled analysis of 2 randomized, double-blind, placebo- and active comparator-controlled phase III clinical trials.
Gan, TJ, Singla, N, Daniels, SE, Lacouture, PG, Min, LH, Reyes, CR, Carr, DB
Journal of clinical anesthesia. 2016;:249-58
Abstract
STUDY OBJECTIVE Long-term use of nonsteroidal anti-inflammatory drugs, including selective and nonselective cyclooxygenase inhibitors, has been suggested to be associated with cardiovascular (CV) safety risks. Data are limited regarding CV risks associated with short-term nonsteroidal anti-inflammatory drug use, including injectable formulations, although it has been suggested that even a single dose may increase CV adverse event (AE) risk. The objective of this study was to examine the CV safety of an injectable diclofenac formulation solubilized with hydroxypropyl-β-cyclodextrin (HPβCD) when given for ≤5days postoperatively. DESIGN A pooled analysis of CV AEs from 2 pivotal phase III clinical trials examining the efficacy and safety of intravenous (IV) HPβCD-diclofenac vs placebo and the active comparator ketorolac was conducted. SETTING Postoperative, with treatment initiated in the postanesthesia care unit ≤6hours postsurgery. PATIENTS Overall, 608 abdominal/pelvic and orthopedic surgery patients met inclusion criteria and received ≥1 study medication dose. INTERVENTIONS Patients received either HPβCD-diclofenac, ketorolac, or placebo via IV bolus injection every 6hours, for ≤5days postsurgery. MEASUREMENTS CV AEs, reported by study investigators, were evaluated through the treatment period and follow-up (≤37days after last study medication dose), and relative CV AE risks were estimated. MAIN RESULTS IV HPβCD-diclofenac was not associated with increased treatment-emergent CV AE incidence vs placebo (11.6% vs 12.2%; relative risk, 0.96 [95% confidence interval, 0.56-1.62]). Serious CV AEs as well as treatment-related AEs were uncommon, and there were no reports of myocardial infarction or cerebrovascular accident. CV AEs were uncommon during the follow-up period, occurring in 1.3%, 0%, and 1.4% of patients in the HPβCD-diclofenac, ketorolac, and placebo groups, respectively. CONCLUSIONS Although a longer duration follow-up study in a larger patient population would expand our understanding of potential CV risks, the present analysis suggests that postoperative use of HPβCD-diclofenac does not present an added CV safety risk over placebo.
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Effectiveness of lumbar zygapophysial joint blockage for low back pain.
Celik, B, Er, U, Simsek, S, Altug, T, Bavbek, M
Turkish neurosurgery. 2011;(4):467-70
Abstract
AIM: Zygapophysial joints have been a well-recognized source of low back pain. This paper compares the efficacy of lumbar zygapophysial joints blockage and medical therapy in terms of pain relief, loss of working days and recurrence of pain in a population with mechanical low back pain. MATERIAL AND METHODS 80 patients suffering from low back pain were included in the study. Patients were divided into 2 groups. Patients in Group I were given diclofenac sodium, thiocolchicoside and were recommended bed rest. Patients in Group II received zygapophysial joints blockage by prilocaine, bupivacaine and methylprednisolone acetate. Both of the groups were evaluated with a Oswestry low back pain disability questionnaire and visual analog scale for pain. RESULTS Posttreatment VAS and ODQ scores were significantly lower than pretreatment scores. The decrease in these scores in Group II was greater than those of Group I. CONCLUSION Blockage of the lumbar facet joints is a rapid and effective way to reduce pain originating from lumbar facet joints.
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Treatments with losartan or enalapril are equally sensitive to deterioration in renal function from cyclooxygenase inhibition.
Juhlin, T, Erhardt, LR, Ottosson, H, Jönsson, BA, Höglund, P
European journal of heart failure. 2007;(2):191-6
Abstract
BACKGROUND The beneficial effects of angiotensin converting enzyme (ACE)-inhibitors are in part mediated through the inhibition of the degradation of the vasodilator bradykinin. The bradykinin effect is counteracted by cyclooxygenase-inhibitors. Angiotensin receptor blockers (ARBs) do not affect bradykinin. AIMS To test the hypothesis that renal counteraction from a cyclooxygenase-inhibitor, diclofenac, is different in subjects treated with an ACE-inhibitor, enalapril compared with an ARB, losartan. METHODS Twelve elderly, healthy, slightly over-hydrated subjects received diclofenac orally after pre-treatment with a diuretic, bendroflumethiazide, and enalapril or bendroflumethiazide and losartan, in a double-blind cross-over fashion, with a wash-out period of at least 1 week. RESULTS Diclofenac reduced GFR significantly from 81(64-98) ml/min at first observations after dose for enalapril to 29(16-42) and from 76(64-88) after losartan to 35(24-46). There was no significant difference between enalapril and losartan in GFR. Diclofenac induced decreases in urine flow, excretion rates and clearances of sodium, osmolality clearance and free water clearance, irrespective of treatment with enalapril or losartan. However, serum potassium and handling of potassium were significantly lower after losartan-treatment. CONCLUSION The negative renal effects of diclofenac administration in subjects with activation of the renin-angiotensin system and enalapril treatment are the same in subjects with activation of the renin-angiotensin system and losartan treatment.
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Chinese herbal recipe versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial [ISRCTN70292892].
Teekachunhatean, S, Kunanusorn, P, Rojanasthien, N, Sananpanich, K, Pojchamarnwiputh, S, Lhieochaiphunt, S, Pruksakorn, S
BMC complementary and alternative medicine. 2004;:19
Abstract
BACKGROUND Duhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking. The purpose of this study was to compare the efficacy of DJW versus diclofenac in symptomatic treatment of osteoarthritis (OA) of the knee. METHODS This study was a randomized, double-blind, double-dummy, controlled trial. The 200 patients suffering from OA of the knee, were randomized into the DJW and diclofenac group. The patients were evaluated after a run-in period of one week (week 0) and then weekly during 4 weeks of treatment. The clinical assessments included visual analog scale (VAS) score that assessed pain and stiffness, Lequesne's functional index, time for climbing up 10 steps, as well as physician's and patients' overall opinions on improvement. RESULTS Ninety four patients in each group completed the study. In the first few weeks of treatment, the mean changes in some variables (VAS, which assessed walking pain, standing pain and stiffness, as well as Lequesne's functional index) of the DJW group were significantly lower than those of the diclofenac group. Afterwards, these mean changes became no different throughout the study. Most of the physician's and patients' overall opinions on improvement at each time point did not significantly differ between the two groups. Approximately 30% of patients in both groups experienced mild adverse events. CONCLUSION DJW demonstrates clinically comparable efficacy to diclofenac after 4 weeks of treatment. However, the slow onset of action as well as approximately equal rate of adverse events to diclofenac might limit its alternative role in treatment of OA of the knee.
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Randomised controlled trial of the onset of analgesic efficacy of dexketoprofen and diclofenac in lower limb injury.
Leman, P, Kapadia, Y, Herington, J
Emergency medicine journal : EMJ. 2003;(6):511-3
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Abstract
OBJECTIVE To assess the time of onset and difference in analgesic efficacy of oral dexketoprofen compared with oral diclofenac in patients with acute lower limb injury. DESIGN A prospective, double blind, randomised controlled trial. INTERVENTIONS Patients who fitted the study criteria were given either 25 mg oral dexketoprofen trometamol or 50 mg sodium diclofenac immediately after triage; baseline and 15 minute pain scores were then recorded for one hour. RESULTS 122 patients were studied (diclofenac = 57 and dexketoprofen = 65). There were no significant differences in age, sex, type of injury, or baseline pain scores between the two groups. The differences in group mean pain scores between diclofenac and dexketoprofen at 15, 30, 45, and 60 minutes were; 0.53 (95% confidence intervals -0.03 to 1.09), 0.70 (0.16 to 1.24), 0.89 (0.32 to 1.47), and 0.83 (0.21 to 1.45). Odds ratios for a decrease in pain score of at least 1 from baseline (on the 11 point scale) when given dexketoprofen rather than diclofenac at 15, 30, 45, and 60 minutes were; 2.66 (1.19 to 5.98), 3.52 (1.60 to 7.73), 4.48 (1.72 to 11.65), and 5.54 (1.90 to 16.15). Corresponding odds ratios for a decrease in pain score of ≥2 were; 6.88 (1.48 to 32.0), 3.79 (1.59 to 9.01), 5.19 (2.29 to 11.78), and 5.87 (2.68 to 12.88). CONCLUSIONS Dexketoprofen trometamol is an effective and rapidly acting analgesic for the treatment of acute musculoskeletal injuries.
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Effects of dexamethasone, diclofenac, or placebo on the inflammatory response after cataract surgery.
Laurell, CG, Zetterström, C
The British journal of ophthalmology. 2002;(12):1380-4
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AIM: To compare the inflammatory response after phacoemulsification and intraocular lens (IOL) implantation using postoperative treatment with dexamethasone, diclofenac, or placebo. METHODS A prospective, randomised, controlled double masked study including 180 patients enrolled for cataract surgery. The patients were 64-85 years old and had no eye disease other than cataract. After phacoemulsification and IOL implantation the patients were randomised to topical treatment with dexamethasone phosphate 0.1% (group I), diclofenac sodium 0.1% (group II), or placebo (saline 0.9%) (group III). The drops were administered four times daily during the first week and twice daily during the second, third, and fourth weeks. The inflammatory reaction in the anterior chamber was measured with laser flare photometry preoperatively and 1, 3, and 8 days, 2 and 4 weeks, 2 and 6 months, and 1, 2, and 4 years postoperatively. Inflammatory symptoms were registered. Biomicroscopy and visual acuity determinations were performed. The rate of Nd:YAG laser posterior capsulotomies after 2 and 4 years was determined. RESULTS After 3 and 8 days (p <0.0001), 2 weeks (p <0.0001), and 1 month (p = 0.0013) median flare was highest in group III. There were no significant differences between group I and II. Inflammatory symptoms and striate keratopathy were more common in group III. CONCLUSION Dexamethasone and diclofenac were equally effective in reducing postoperative inflammation after phacoemulsification and IOL implantation in eyes with no other disease than cataract. Both substances were more effective than placebo.
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Topical diclofenac sodium for treatment of postoperative inflammation in cataract surgery.
Reddy, MS, Suneetha, N, Thomas, RK, Battu, RR
Indian journal of ophthalmology. 2000;(3):223-6
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Abstract
PURPOSE To study the effect of a topical non-steroidal anti-inflammatory drug as an alternative to topical steroids for postoperative control of inflammation in cataract surgery. METHODS The effect of diclofenac sodium 0.1% following cataract surgery was studied and compared to routine corticosteroid, dexamethasone phosphate 1% in a prospective, double-blind randomized study. Both groups were similar in baseline parameters. Postoperative inflammatory response, intraocular pressure and best-corrected visual acuity following standard extracapsular cataract extraction were assessed in both groups in the initial 21 days and the severity of these parameters was graded. The severity of postoperative inflammatory response to the two drugs was graded at 1, 3, 7, 14 and 21 days. Intraocular pressure and visual acuity at baseline and endpoint were compared and statistically analyzed. RESULTS The two groups did not differ statistically in treatment effect for any of the variables including aqueous cells, flare, ciliary congestion, Descemet's folds, visual acuity and intraocular pressure (p < 0.001). However there seemed to be a trend towards quicker improvement with corticosteroid when cells in the anterior chamber were considered. There were no side effects from topical diclofenac, and it was well tolerated. CONCLUSION Diclofenac sodium is as effective as topical corticosteroid and can be used as an alternative in routine postoperative treatment following uncomplicated cataract surgery.
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Analgesic effect of topical sodium diclofenac 0.1% drops during retinal laser photocoagulation.
Weinberger, D, Ron, Y, Lichter, H, Rosenblat, I, Axer-Siegel, R, Yassur, Y
The British journal of ophthalmology. 2000;(2):135-7
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AIMS: To evaluate the analgesic effect of topical sodium diclofenac 0.1% during retinal laser photocoagulation. METHODS 87 patients, 45 with proliferative diabetic retinopathy treated with two sessions of panretinal photocoagulation (group A), and 42 patients with non-proliferative diabetic retinopathy who underwent grid treatment of the posterior pole (19 bilaterally) (group B). Sodium diclofenac 0.1% or sodium chloride 0.9% drops were topically applied 30-135 minutes before laser treatment in a masked fashion. Patients who had two sessions were given the alternate drug in the second one. Pain level was evaluated immediately after laser treatment with the visual analogue scale (VAS). The results were statistically analysed. RESULTS Patients in group A reported pain in 85/90 sessions (94%). The average pain level was 44.2% with sodium diclofenac 0.1% drops and 53.1% with sodium chloride 0.9% drops (p = 0.011 by paired t test). Patients in group B reported pain in only 16/60 sessions (26. 7%), and the pain level ranged from 10% to 60% regardless of the kind of drops used. There was no correlation in either group between level of pain and time interval from application of the drops to laser treatment (30-135 minutes) or average energy level used (100-500 mW). CONCLUSION Sodium diclofenac 0.1% is useful for pain reduction and should be applied before panretinal photocoagulation.