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Pre-Emptive Effect of Dexamethasone and Diclofenac Sodium Associated With Codeine on Pain, Swelling, and Trismus After Third Molar Surgery: A Split-Mouth, Randomized, Triple-Blind, Controlled Clinical Trial.
Lima, TC, Bagordakis, E, Falci, SGM, Dos Santos, CRR, Pinheiro, MLP
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2018;(1):60-66
Abstract
PURPOSE We aimed to compare the effect of dexamethasone, 8 mg, and diclofenac sodium, 50 mg, associated with codeine, 50 mg, on the control of pain, swelling, and trismus after extraction of impacted third molars. MATERIALS AND METHODS Fifteen healthy patients with a mean age of 22.8 years (SD, 12.62 years) received a single oral dose of either drug 1 hour before each surgical procedure (left and right teeth). At 24, 48, and 72 hours after surgery, swelling was determined by use of linear measurements on the face and trismus was determined by maximal mouth opening. Postoperative pain was self-recorded by the patients using a numerical rating scale at 24-hour intervals for a period of 72 hours. Data analysis involved descriptive statistics and Shapiro-Wilk, Wilcoxon, and paired t tests (P < .05). RESULTS Dexamethasone controlled pain (P = .016) and edema (P = .08) within 48 hours better than diclofenac sodium associated with codeine. No statistically significant differences were found between drugs regarding trismus and consumption of rescue analgesics (acetaminophen). CONCLUSIONS The results of this study suggest that pre-emptive administration of dexamethasone, 8 mg, showed better control of pain and swelling in bilateral extractions of third impacted mandibular molars.
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Comparison of three analgesic drug regimens with twelfth subcostal nerve block for pain control during extracorporeal shock wave lithotripsy.
Maldonado-Avila, M, Garduño-Arteaga, LM, Vela-Mollinedo, RA, Jaspersen-Gastelum, J, Virgen-Gutierrez, F, Del Rosario-Santiago, M, Rios-Davila, V
International urology and nephrology. 2018;(1):49-53
Abstract
INTRODUCTION AND OBJECTIVE Extracorporeal shock wave lithotripsy (ESWL) is the first-line treatment in the majority of cases of upper urinary tract stones. Since its introduction, attempts have been made to establish the ideal accompanying analgesic method to enable the application of shock waves of adequate duration and intensity for efficacious stone fragmentation. An open, randomized, prospective, longitudinal, comparative, and experimental clinical study was conducted to evaluate the efficacy of subcostal nerve block with lidocaine, comparing it in combination with tramadol or diclofenac for pain control during ESWL. MATERIALS AND METHODS Seventy patients of both sexes were included in the study. Thirty-five were men and 35 were women, all above 18 years of age, with kidney stones or ureteral stones smaller than 20 mm. The patients were randomly assigned to one of the following groups: Group 1 (24 patients) Twelfth subcostal nerve block with 10 ml of lidocaine 2%, 5 min before ESWL. Group 2 (25 patients) Twelfth subcostal nerve block with 10 ml lidocaine 2% + intramuscular diclofenac sodium 45 min before ESWL. Group 3 (21 patients) Twelfth subcostal nerve block with 10 ml of lidocaine 2% + tramadol at 1 mg/Kg of weight, 45 min before ESWL. The visual analog scale (VAS) for pain was applied at minutes 10, 20, and 30 of the procedure. RESULTS No statistically significant differences were reported by the ANOVA test for comparing the mean pain values between the three groups at minutes 10, 20, and 30 of the ESWL. There were no adverse effects. CONCLUSIONS Even though there were no statistically significant differences between the three groups, the analgesic regimen of twelfth subcostal nerve block with lidocaine 2%, alone, was as efficacious as its combination with other analgesics and therefore can be used as a sole analgesic method during ESWL.
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Analysis of diclofenac in water samples using in situ derivatization-vortex-assisted liquid-liquid microextraction with gas chromatography-mass spectrometry.
Aydin, S, Aydin, ME, Beduk, F, Tekinay, A, Kilic, H
Acta pharmaceutica (Zagreb, Croatia). 2018;(3):313-324
Abstract
A novel micro-extraction technique for a rapid and sensitive analysis of diclofenac (DCF) in water samples has been developed. DCF was derivatized and extracted simultaneously using vortex-assisted liquid-liquid micro-extraction (VALLME) prior to gas chromatography with mass spectrometry detection. The effects of extraction solvent volume, extraction and derivatization time and ionic strength of the sample were studied using 23 factorial experimental design. The optimum extraction conditions were as follows: 200 μL of chloroform, 25 μL of N-methyl-N-trimethylsilyl-trifluoroacetamide (MSTFA) derivatization reagent, vortex extraction and derivatization time 5 min at 3000 rpm. The extraction recovery for different fortification levels was 98 %. Also, the proposed micro-extraction method exhibited results comparable with the solid phase extraction of real water samples. The proposed one-step VALLME and derivatization method is simpler and faster than the conventional extraction and derivatization methods used for the determination of DCF in real water samples.
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Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports.
Moore, RA, Derry, S
Pain research & management. 2018;:9493413
Abstract
We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519), gynaecological surgery (3 trials, n=679), and dysmenorrhoea (2 trials, n=711) conducted in 1988-1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT) from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9-2.6) and 2.1 (1.8-2.4) for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.
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Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial.
Gorecki, P, Rainsford, KD, Taneja, P, Bulsara, Y, Pearson, D, Saund, D, Ahmed, B, Dietrich, T
Journal of dental research. 2018;(4):381-387
Abstract
Diclofenac sodium is a widely used nonsteroidal anti-inflammatory drug (NSAID) for relief of inflammatory pain. A recent formulation combines this drug with hydroxypropyl-β-cyclodextrin (HPβCD) to improve its solubility and to enable subcutaneous administration. Previous studies confirmed the efficacy of this combination. This study's aim was to evaluate the efficacy, safety, and local tolerability of diclofenac HPβCD administered as a local submucosal injection prior to lower third molar surgery. We conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group phase II single-center study. Seventy-five patients requiring mandibular third molar surgery were randomized into 1 of 5 groups: 5 mg/1 mL diclofenac HPβCD, 12.5 mg/1 mL diclofenac HPβCD, 25 mg/1 mL diclofenac HPβCD, 50 mg/1 mL diclofenac HPβCD, or 1 mL placebo. The respective study drug was injected into the mucosal tissue surrounding the surgical site prior to surgery following achievement of local anesthesia. The primary outcome measure was the area under the curve (AUC) of cumulative pain scores from end of surgery to 6 h postsurgery. This demonstrated a global treatment effect between the active groups and placebo, hence confirming the study drug's efficacy ( P = 0.0126). Secondary outcome measures included the time until onset of pain and the time until patients required rescue medication, both showing statistical significance of the study drug compared to placebo ( P < 0.0161 and P < 0.0001, respectively). The time until rescue medication ranged between 7.8 h (for 25 mg/1 mL diclofenac HPβCD) and 16 h (for 50 mg/1 mL diclofenac HPβCD). Interestingly, the 5-mg/1-mL solution appeared superior to the 12.5-mg/1-mL and 25-mg/1-mL solutions (time until rescue medication = 12.44 h). A total of 14% of patients experienced minor adverse drug reactions (ADRs), of which 2 cases demonstrated flap necrosis. These resolved without further intervention. The study results overall indicate efficacy, safety, and relative tolerability of diclofenac HPβCD used locally as a submucosal injection prior to third molar surgery (ClinicalTrials.gov NCT01706588).
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Intravitreal Diclofenac plus Bevacizumab versus Bevacizumab alone in treatment-naive diabetic macular edema: a randomized double-blind clinical trial.
Ghanbari, H, Kianersi, F, Sonbolestan, SA, Abtahi, MA, Akbari, M, Abtahi, ZA, Abtahi, SH
International ophthalmology. 2017;(4):867-874
Abstract
The aim of this study is to evaluate the short-term effects of a single intravitreal injection of 1.25 mg Bevacizumab combined with 300 lg/0.1 mL Diclofenac (IVB/D) versus 1.25 mg intravitreal Bevacizumab (IVB) alone in the treatment of naive diabetic macular edema (DME). In this prospective, randomized clinical trial, 80 eyes were included in the final analysis; 42 and 38 of which in the IVB and IVB/D groups, respectively. The primary outcome measure was a change in best-corrected visual acuity (BCVA) in logMAR at week 4. The secondary outcomes included changes in central macular thickness (CMT), macular volume, and potential injection-related complications. Significant improvement of BCVA was demonstrated in both study arms (mean reductions in LogMAR: -0.088 ± 0.278, -0.228 ± 0.330 for IVB and IVB/D, respectively). The difference in BCVA changes was in favor of IVB/D; however, not to a statistically significant level (P = 0.160). Significant reduction of CMT was documented in both study arms (mean reductions: 82.43 ± 160.09 and 153.26 ± 163.85 for IVB and IVB + IVD, respectively). Comparison of CMT changes between groups showed that IVB/D reduced CMT more than that of IVB (P = 0.04). Effects on macular volume corresponded to those of CMT. No injection-related complications or significant alterations in intraocular pressure were observed in any of the study arms. In treatment-naive DME, superiority of IVB/D combination therapy over IVB monotherapy may exist; especially as regards anatomical features. In our therapeutic arsenal for DME, IVD can be added as an adjunct to Bevacizumab.
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Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial.
Hauser, G, Blažević, I, Salkić, N, Poropat, G, Giljača, V, Bulić, Z, Štimac, D
Surgical endoscopy. 2017;(2):602-610
Abstract
BACKGROUND AND AIMS We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP. RESULTS Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86-3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis. CONCLUSIONS The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP. CLINICAL TRIALS. GOV NUMBER NCT 01784445.
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Comparison of Clinical Effectiveness and Safety of Newer Nonsteroidal Anti-inflammatory Drugs in Patients of Osteoarthritis of Knee Joint: A Randomized, Prospective, Open-label Parallel-group Study.
Garg, Y, Singh, J, Sohal, HS, Gore, R, Kumar, A
Indian journal of pharmacology. 2017;(5):383-389
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Abstract
OBJECTIVE Osteoarthritis (OA) is a chronic progressive degenerative disease of weight-bearing joints and the leading cause of disability in elderly. Current medical management of OA is mostly palliative with nonsteroidal anti-inflammatory drugs (NSAIDs) being the mainstay of therapy. Reports of gastrointestinal adverse effects with traditional NSAIDs and cardiovascular adverse effects associated with selective cyclooxygenase-2 (COX-2) inhibitors have prompted the hunt for a better NSAID with no or minimal adverse effects. This study compares the clinical effectiveness and safety of newer NSAIDS etodolac and lornoxicam to diclofenac which has been a standard therapy in patients of OA of knee joint. MATERIALS AND METHODS It was a randomized, prospective, open-label, parallel-group study conducted in 90 patients of OA of knee joint diagnosed according to the American College of Rheumatology criteria. After obtaining the informed consent, they were randomized in three groups of 30 patients each who received tablet etodolac 400 mg b.i.d, tablet lornoxicam 8 mg b.i.d, and tablet diclofenac sodium 50 mg t.i.d, respectively. The duration of the study was 12 weeks. Data were tabulated and analyzed using analysis of variance (ANOVA) test, and level of significance was determined by its P value. RESULTS After 12 weeks of treatment, pain intensity and functional indices in terms of visual analog scale and Western Ontario and McMaster Universities Osteoarthritis score were significantly better (P < 0.05) in lornoxicam group as compared to etodolac or diclofenac group along with lesser rate of adverse effects. CONCLUSION It was concluded that lornoxicam was more effective and better tolerated NSAID than etodolac and diclofenac in treatment of knee joint OA.
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Analgesic Effect of Topical Sodium Diclofenac before Retinal Photocoagulation for Diabetic Retinopathy: A Randomized Double-masked Placebo-controlled Intraindividual Crossover Clinical Trial.
Ramezani, A, Entezari, M, Shahbazi, MM, Semnani, Y, Nikkhah, H, Yaseri, M
Korean journal of ophthalmology : KJO. 2017;(2):102-107
Abstract
PURPOSE To evaluate the analgesic effect of topical sodium diclofenac 0.1% before retinal laser photocoagulation for diabetic retinopathy. METHODS Diabetic patients who were candidates for peripheral laser photocoagulation were included in a randomized, placebo-controlled, intraindividual, two-period, and crossover clinical trial. At the first session and based on randomization, one eye received topical sodium diclofenac 0.1% and the other eye received an artificial tear drop (as placebo) three times before laser treatment. At the second session, eyes were given the alternate drug. Patients scored their pain using visual analogue scale (max, 10 cm) at both sessions. Patients and the surgeon were blinded to the drops given. Difference of pain level was the main outcome measure. RESULTS A total of 200 eyes of 100 patients were enrolled. Both treatments were matched regarding the applied laser. Pain sensation based on visual analogue scale was 5.6 ± 3.0 in the treated group and 5.5 ± 3.0 in the control group. The calculated treatment effect was 0.15 (95% confidence interval, -0.27 to 0.58; p = 0.486). The estimated period effect was 0.24 (p = 0.530) and the carryover effect was not significant (p = 0.283). CONCLUSIONS Pretreatment with topical sodium diclofenac 0.1% does not have any analgesic effect during peripheral retinal laser photocoagulation in diabetic patients.
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Effect of preoperative topical diclofenac on intraocular interleukin-12 concentration and macular edema after cataract surgery in patients with diabetic retinopathy: a randomized controlled trial.
Medić, A, Jukić, T, Matas, A, Vukojević, K, Sapunar, A, Znaor, L
Croatian medical journal. 2017;(1):49-55
Abstract
AIM: To determine if preoperative treatment with a topical non-steroidal anti-inflammatory drug (NSAID) lowers the concentration of intraocular interleukin (IL)-12 and the incidence of postoperative macular edema in patients with non-proliferative diabetic retinopathy undergoing cataract surgery. METHODS A total of 55 patients were randomized to diclofenac (n=27) or placebo (n=28). Patients receiving diclofenac started preoperative treatment with 0.1% topical diclofenac four times a day 7 days before cataract surgery and the therapy was discontinued 30 days after surgery. Patients in the control group were administered placebo 7 days preoperatively and a standard postoperative therapy with 0.1% topical dexamethasone four times a day for 30 days after surgery. All patients received postoperative antibiotic prophylaxis with tobramycin eye drops four times daily for 30 days. Seven days before the cataract surgery, on the day of surgery, and 1, 7, 30, and 90 days after surgery, central foveal thickness (CFT) was measured with optical coherence tomography (OCT) and the aqueous humor was sampled at the beginning of cataract surgery for the analysis of IL-12 concentration. Due to loss to follow-up and insufficient aqueous humor samples, the data of 3 patients treated with diclofenac and 8 patients receiving placebo were not analyzed. RESULTS The aqueous humor IL-12 concentration was significantly lower in the diclofenac group than in the placebo group (t=-2.85, p=0.007). The diclofenac group had a significantly smaller increase in CFT after phacoemulsification (F=13.57, p<0.001). CONCLUSION Patients preoperatively treated with diclofenac had significantly lower intraocular levels of IL-12 and a lower increase in CFT, which indicates that a combination of preoperative and postoperative treatment with a topical NSAID may lower the incidence of postoperative macular edema in patients with diabetic retinopathy.