Analgesic Efficacy of Preoperative Parecoxib Sodium in an Orthopedic Pain Model

2004 ◽  
Vol 94 (3) ◽  
pp. 305-314 ◽  
Author(s):  
Paul J. Desjardins ◽  
Louise Traylor ◽  
Richard C. Hubbard
Keyword(s):  
Placebo Group ◽  
Postoperative Pain ◽  
Confidence Interval ◽  
Rescue Medication ◽  
Analgesic Efficacy ◽  
Selective Inhibitor ◽  
Efficacy And Safety ◽  
Pain Model ◽  
Preoperative Administration ◽  
The Mean

The efficacy and safety of preoperative intravenous administration of parecoxib sodium, a novel parenteral prodrug of a cyclooxygenase-2 selective inhibitor, in treating postoperative pain resulting from bunionectomy were evaluated in 50 patients who were part of a larger cohort of orthopedic and podiatric patients. Following bunionectomy, the median time to rescue medication (survival analysis) was 4 hours 18 min (95% confidence interval, 3 hours 4 min to 4 hours 37 min) in the placebo group, 7 hours 5 min (95% confidence interval, 3 hours 20 min to >24 hours) in the 20-mg parecoxib sodium group, and 10 hours 43 min (95% confidence interval, 4 hours 42 min to 14 hours 7 min) in the 40-mg parecoxib sodium group (significant for 40-mg parecoxib sodium versus placebo). Four or more hours after surgery, the mean pain-intensity (categorical) score was significantly lower in both parecoxib sodium groups than in the placebo group. Preoperative administration of parecoxib sodium was well tolerated and significantly reduced postoperative pain in patients who had undergone bunionectomy. (J Am Podiatr Med Assoc 94(3): 305–314, 2004)

scholarly journals Efficacy and safety of oral tolvaptan in patients undergoing hemodialysis: a Phase 2, double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hiroaki Ogata ◽  
Naoko Shimofurutani ◽  
Tadashi Okada ◽  
Hisashi Nagamoto ◽  
Tadao Akizawa
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Urine Volume ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Fluid Removal ◽  
Interdialytic Weight Gain ◽  
The Mean ◽  
Total Fluid

Abstract Background Loop diuretics are used to manage fluid retention in patients with end-stage kidney disease undergoing hemodialysis (HD). This randomized, double-blind, placebo-controlled, Phase 2 trial evaluated the efficacy and safety of tolvaptan, a vasopressin V2 receptor antagonist, in Japanese HD patients. Methods A total of 124 patients (24-h urine volume ≥500 mL) on thrice-weekly HD were randomized to receive oral tolvaptan 15 mg/day (n = 40), tolvaptan 30 mg/day (n = 40) or placebo (n = 44) for 24 weeks. Efficacy endpoints were change from baseline in 24-h urine volume, total fluid removal by HD per week and interdialytic weight gain (IDWG). Safety was assessed via the incidence of treatment-emergent adverse events (TEAEs). Results At treatment end, the difference (95% confidence interval) from the placebo group in the mean change from baseline in 24-h urine volume was significant in the tolvaptan 15 mg {429.1 mL [95% confidence interval (CI) 231.0, 627.2]; P < 0.0001} and 30 mg [371.6 mL (95% CI 144.1, 599.2); P = 0.0017] groups. The mean changes from baseline in total fluid removal by HD and IDWG were not significantly different in the tolvaptan groups versus the placebo group. Although the proportion of patients with TEAEs was lower in the placebo group (77.3%) than in the tolvaptan groups (92.3%), tolvaptan was safe and well-tolerated during the study period. Conclusions Tolvaptan significantly sustained diuretic action for 24 weeks in HD patients but did not reduce total fluid removal by HD per week and IDWG to the same extent.

Cost-efficacy of Rofecoxib versus  Acetaminophen for Preventing Pain after Ambulatory Surgery

2002 ◽  
Vol 97 (4) ◽  
pp. 931-937 ◽  
Author(s):  
Tijani Issioui ◽  
Kevin W. Klein ◽  
Paul F. White ◽  
Mehernoor F. Watcha ◽  
Gary D. Skrivanek ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Pain Management ◽  
Postoperative Pain ◽  
Confidence Interval ◽  
Analgesic Efficacy ◽  
Additional Patient ◽  
Controlled Study ◽  
Quality Of Recovery ◽  
Analgesic Medication

Background Nonsteroidal antiinflammatory drugs are commonly administered as part of a multimodal regimen for pain management in the ambulatory setting. This randomized, double-blinded, placebo-controlled study was designed to compare the analgesic effect of oral rofecoxib, a cyclooxygenase-2 inhibitor, and acetaminophen when administered alone or in combination prior to outpatient otolaryngologic surgery. Methods A total of 143 healthy outpatients undergoing elective otolaryngologic surgery were assigned to one of four study groups: group 1 = control (500 mg vitamin C); group 2 = 2 g acetaminophen; group 3 = 50 mg rofecoxib; or group 4 = 2 g acetaminophen and 50 mg rofecoxib. The first oral dose of the study medication was taken 15-45 min before surgery, and a second dose of the same medication was administered on the morning after surgery. Recovery times, side effects, and the need for rescue analgesics were recorded. Follow-up evaluations were performed at 24 and 48 h after surgery to assess postdischarge pain, analgesic requirements, nausea, and patient satisfaction with their postoperative pain management and quality of recovery. Peak pain scores and the need for rescue analgesic medication were used as the endpoints for estimating efficacy of the study drugs, while cost to achieve complete satisfaction with analgesia was used in the cost-effectiveness analysis. Results Premedication with rofecoxib (50 mg) was significantly more effective than either placebo or acetaminophen (2 g) in reducing the peak postoperative pain, the need for analgesic medication, and improving the quality of recovery and patient satisfaction. Moreover, the addition of acetaminophen failed to improve its analgesic efficacy. An expenditure for rofecoxib of 16.76 US dollars (95% confidence interval, 7.89 to 21.03 US dollars) and 30.24 US dollars (95% confidence interval, 5.25 to 54.20 US dollars) would obtain complete satisfaction with pain control in one additional patient who would not have been satisfied if placebo or acetaminophen, respectively, had been administered prior to surgery. Conclusions Rofecoxib, 50 mg administered orally, decreased postoperative pain and the need for analgesic rescue medication after otolaryngologic surgery. The addition of 2 g oral acetaminophen failed to improve its analgesic efficacy.

Analgesic efficacy and safety of single-dose intramuscular ketorolac for postoperative pain management in children following tonsillectomy

Pain ◽  
1995 ◽  
Vol 61 (1) ◽  
pp. 145-153 ◽  
Author(s):  
Kimberly A. Sutters ◽  
Jon D. Levine ◽  
Suzanne Dibble ◽  
Marilyn Savedra ◽  
Christine Miaskowski
Keyword(s):  
Single Dose ◽  
Pain Management ◽  
Postoperative Pain ◽  
Analgesic Efficacy ◽  
Postoperative Pain Management ◽  
Efficacy And Safety ◽  
Intramuscular Ketorolac

scholarly journals Therapeutic Effects of Add-On Tenapanor for Hemodialysis Patients with Refractory Hyperphosphatemia

2021 ◽  
pp. 1-11
Author(s):  
Takashi Shigematsu ◽  
Yotaro Une ◽  
Kazuaki Ikejiri ◽  
Hironori Kanda ◽  
Masafumi Fukagawa ◽  
...  
Keyword(s):  
Placebo Group ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Therapeutic Effects ◽  
Efficacy And Safety ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
The Mean ◽  
Phosphorus Levels

<b><i>Introduction:</i></b> Phosphate binders are used to treat hyperphosphatemia. Some patients have inappropriately controlled serum phosphorus levels, which may occur for many reasons, including a high pill burden and adverse events (AEs). Tenapanor selectively inhibits the passive paracellular transfer of phosphate in the gastrointestinal tract, thereby reducing serum phosphorus levels. This novel mechanism of action may contribute to improved phosphate management. The efficacy and safety of tenapanor have not been evaluated in Japanese patients with high serum phosphorus levels despite treatment with phosphate binders. This study aimed to assess the efficacy and safety of add-on tenapanor therapy for reducing serum phosphorus levels in this population. <b><i>Methods:</i></b> This multicenter, double-blind, randomized, placebo-controlled trial enrolled patients with refractory hyperphosphatemia undergoing hemodialysis. Patients were randomly assigned in a 1:1 ratio to receive tenapanor or placebo as an add-on to their phosphate binder regimen for 6 weeks. Change in serum phosphorus levels at week 6 (day 43) compared with the baseline value (day 1, week 0) (primary endpoint), achievement of target serum phosphorus levels (serum phosphorus level ≤6.0 or ≤5.5 mg/dL), and safety, based on all AEs and drug-related AEs, were among the outcomes evaluated. <b><i>Results:</i></b> In total, 24 patients were randomly assigned to the placebo group and 23 to the tenapanor group. The mean serum phosphorus level decreased from 7.01 mg/dL on day 1 to 6.69 mg/dL on day 43 in the placebo group and from 6.77 mg/dL on day 1 to 4.67 mg/dL on day 43 in the tenapanor group. In the placebo and tenapanor groups (modified intent-to-treat population), the mean (standard deviation) change in the serum phosphorus level at day 43 (last observation carried forward [LOCF]) was 0.08 (1.52) mg/dL and −1.99 (1.24) mg/dL, respectively, with a between-group difference of −2.07 (95% confidence interval: −2.89, −1.26; <i>p</i> &#x3c; 0.001). The target achievement rate (serum phosphorus level ≤6.0 mg/dL at week 6 [LOCF]) was 37.5 and 87.0% in the placebo and tenapanor groups, respectively. Diarrhea was the most common drug-related AE, and it occurred in 8.3 and 65.2% of patients in the placebo and tenapanor groups, respectively. No specific AEs were observed with add-on tenapanor or with phosphate binders. <b><i>Discussion/Conclusion:</i></b> Therapy with existing phosphate binders and add-on tenapanor resulted in a significant decrease in serum phosphorus level compared with the placebo group in patients with refractory hyperphosphatemia despite treatment with phosphate binders. No new safety signals were raised, and add-on tenapanor was generally well tolerated.

P0880EFFICACY AND SAFETY OF SEVELAMER CARBONATE IN NON-DIALYSIS HYPERPHOSPHATEMIA PATIENTS: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP STUDY FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE NOT ON DIALYSIS IN CHINA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xueqing Yu
Keyword(s):  
Chronic Kidney Disease ◽  
Placebo Group ◽  
Kidney Disease ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Sevelamer Carbonate ◽  
The Mean

Abstract Background and Aims Hyperphosphatemia in chronic kidney disease (CKD) patients is associated with adverse outcomes, including vascular calcification, increasing risks of disease progression and even death. Sevelamer carbonate have been approved in Europe for phosphate lowering treatment in pre-dialysis CKD patient, its efficacy and safety in Chinese CKD hyperphosphatemia patients are not previously reported. Method This was a phase III, multi-center, randomized, double blind, placebo-controlled, balanced (1:1, sevelamer: placebo) parallel-group study to evaluate the efficacy and safety of sevelamer carbonate versus placebo over 8 weeks’ duration in hyperphosphatemic CKD patients not on dialysis in China (Registration number NCT03001011). The primary objective of this study is to demonstrate efficacy of sevelamer carbonate tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease (CKD) not on dialysis. Results In all, 202 patients were randomized (sevelamer, n=101; placebo, n=101); mean age was 50.7 years, 53.5% were male and the mean time of CKD diagnosis was 3.4 years with mean eGFR 7.5 ml/min/1.73 m2. The baseline phosphorous were 2.13±0.35 mmol/L and 2.12±0.37 mmol/L in sevelamer and placebo group, respectively. The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate (-0.22±0.47 mmol/L) compared with placebo (0.05±0.44 mmol/L) (mean difference between sevelamer carbonate and placebo was -0.26 mmol/L, P&lt;0.0001). When compared with placebo, sevelamer carbonate significantly reduced serum total cholesterol (-0.90±0.85 vs. -0.06±0.68 mmol/L, P&lt;0.0001), low-density lipoprotein cholesterol (-0.94±0.72 vs. -0.04±0.58 mmol/L, P&lt;0.0001) and calcium-phosphorous product (-0.48±0.97 vs. 0.05±0.81 mmol2/L2) from baseline to week 8. Serum iPTH was not significantly changed in sevelamer carbonate group compared with placebo group (-9.60±136.00 vs. 7.61±141.92 ng/L, P=0.83). Sevelamer carbonate was well tolerated with 83.27% compliance compared with 82.19% compliance in placebo arm. Average dose of sevelamer carbonate was 7.51 g/d at the end of study and 4.52 g/d across the study. Adverse events experienced by patients in sevelamer carbonate and placebo group were similar. Conclusion This study demonstrated that sevelamer carbonate has produced a significant reduction of serum phosphorous, and is safe and tolerated in Chinese pre-dialysis CKD patients with hyperphosphatemia.

scholarly journals A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF LORNOXICAM AND DICLOFENAC AS POSTOPERATIVE ANALGESICS AFTER MASTOIDECTOMY SURGERY

2017 ◽  
Vol 9 (2) ◽  
pp. 77 ◽  
Author(s):  
R. Nalini ◽  
J. Ezhilramya
Keyword(s):  
Postoperative Pain ◽  
Rescue Medication ◽  
P Value ◽  
Efficacy And Safety ◽  
Serious Adverse Event ◽  
Primary Parameter ◽  
Randomised Study ◽  
Group A ◽  
Group 3 ◽  
Group B

<p><strong>Objective</strong>:<strong> </strong>The objective of the research was to evaluate the efficacy and safety of lornoxicam compared to diclofenac in the management of postoperative pain following mastoidectomy surgery.<strong> </strong></p><p><strong>Methods: </strong>The present study was a<strong> </strong>prospective, single-blinded, randomised study. 80 mastoidectomy patients were randomised into two groups. Group A received lornoxicam 8 mg and group B received diclofenac 75 mg intramuscularly twice daily for 3 consecutive days. The primary parameter was to analyse the postoperative pain using visual analogue scale (VAS) and Wong Bakers scale (WBS). The secondary parameters were the usage of rescue medication and time to use rescue medication.</p><p><strong>Results</strong>:<strong> </strong>There was a significant reduction in the postoperative pain in the lornoxicam group than the diclofenac group (p value&lt;0.05) throughout the study. Significantly 11 patients required rescue medication in diclofenac group, 3 patients in lornoxicam group. No serious adverse event was noted in two groups.</p><p><strong>Conclusion: </strong>Lornoxicam 8 mg was a better analgesic than diclofenac 75 mg in efficacy and safety in the management of postoperative pain following mastoidectomy surgery.</p>

scholarly journals Investigation of apomorphine during sleep in Parkinson’s: Improvement in UPDRS Scores

2019 ◽  
Vol 11 (4) ◽  
Author(s):  
Miguel A. Pieroni
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Rem Sleep ◽  
Therapeutic Approach ◽  
Dopamine Agonists ◽  
D2 Receptors ◽  
Significant Benefit ◽  
The Mean ◽  
Updrs Part ◽  
Stimulation Of

Sleep is responsible for several functions required for homeostasis. REM sleep could be a rearrangement period where limits of certain functions can be moved to a new state of balance. This study proposes that dopaminergic deficit may be responsible for the circadian dysregulation that occur with neurodegeneration and therefore a restitution of REM sleep and an improvement in Parkinson disease’s symptoms can be achieved with the controlled use of dopamine agonists during the night. Twenty parkinsonian patients underwent to a onemonth study of subcutaneous nocturnal apomorphine treatment at the beginning of each REM stage. This therapeutic approach led to a significant benefit for patients in all of the 3 UPDRS scores. The mean change from baseline in the MDS-UPDRS Part I, II and III was significantly greater in the apomorphine vs. placebo group. In the UPDRS Part I total score was 0.8 (95% confidence interval [CI]: 1.612, -0.012) and 3.3 (95% CI: 4.732, 1.867) for the placebo and apomorphine groups, respectively (difference between groups: 2.5, 95% CI: 3.454, 1.545; P = 0.002). For UPDRS Part II total score, the mean change was 1.3 (95% CI: 2.692, - 0.09) and 4.6 (6.916, 2.28). Difference between groups: 3.3, 95% CI: 4.752, 1.847; P = 0.013. In UPDRS Part III was 1.1 (95% CI: 2.425, -0.225) and 5.5 (95% CI: 8.808, 2.191). Difference between groups: 4.4, (95% CI: 6.321, 2.478; P = 0.012). We can conclude that sleep alteration in PD can be improved by stimulation of D2 receptors. The symptomatic benefits obtained due to restoration of REM functions were significant.

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