Search results for "randomized controlled trial"

Oral trasmucosal fentanyl citrate for breakthrough pain treatment in cancer patients.

2012

Breakthrough cancer pain has been defined as a transitory increase in pain intensity that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. The availability of supplemental doses of oral opioids, in addition to the continuous analgesic medication, is the main treatment suggested to manage pain flares.Oral transmucosal fentanyl citrate (OTFC) is the first product of a new generation of delivery systems, named rapid-onset opioids (ROOs), characterized by rapidity of effect and the short duration of analgesia. Controlled studies and long-term experience have shown that OTFC is an e…

Authors' response to Hermann et al. Minimum quality criteria are needed in the assessment and communication of unexpected drug safety findings of mar…

2012

Hermann et al. [1] suggest that minimum quality criteria are needed to communicate unexpected drug safety findings from randomized clinical trials and imply that our report on unexpected frequent hepatotoxicity in patients receiving flupirtine for the treatment of overactive bladder syndrome [2] does not meet such criteria. As the brief report format of our paper did not allow an extensive description of trial details, we welcome this opportunity to shed more light on the matter.

Oral metamizol (1 g and 2 g) versus ibuprofen and placebo in the treatment of lower third molar surgery pain: randomised double-blind multi-centre st…

1998

Objective: To assess the efficacy of metamizol 1 g and 2 g in the relief of pain after surgical extraction of the lower third molar, and to compare the therapeutic effect with that of ibuprofen 600 mg or placebo.

Control of HIV-infection with Visits Scheduled Every Four or Every Six Months. A Comparative Randomized Study

2011

Histamine release during induction of anaesthesia and preparation for operation in patients undergoing general surgery: Incidence and clinically seve…

1992

Histamine release events were shown in a prospective randomized controlled trial in patients undergoing elective general surgery with an extraordinarily high incidence: 73 per cent. This high incidence was explained by several factors: — the sample size which was much greater than in previous studies — the improved plasma histamine assay — the precise definition of histamine release in clinical conditions and its measurement at the top of Bateman functions — the standardized induction of anaesthesia and preparation of the surgical patient — and finally the considerable number of cancer patients since more than 60% of the reactions >5 ng/ml occurred in this group which comprised only 20% of …

Intramuscular tramadol versus ketorolac in patients with orthopedic and traumatologic postoperative pain: a comparative multicenter trial

1998

This 3-day, multicenter, open-label, randomized, controlled trial was undertaken to assess the postoperative analgesic effect and therapeutic safety of intramuscular tramadol compared with intramuscular ketorolac in 48 patients undergoing orthopedic surgery and having postoperative pain assessed as 75 mm or more on a 100-mm visual analogue scale. Tramadol (100 mg/2 mL ampules) was administered as needed to a maximum of 400 mg/d, and ketorolac (30 mg/1 mL ampules) was given as needed up to 90 mg/d. Nine patients who received tramadol and six who received ketorolac needed only one dose of medication to achieve satisfactory analgesia. Tramadol had a more pronounced analgesic effect than did ke…

Methodological Problems in RCTs on IBD

2012

Abstract: Randomized controlled trials (RCTs) are the gold standard method for developing evidence-based medicine in inflammatory bowel disease (IBD). Methodological problems in RCTs in IBD concern different aspects such as the definition of the study population due to the extreme variability of patients with IBD, the indices of disease activity, a clearly defined outcome, the environmental risk factors (i.e smoking behaviour) that may influence the randomization, the heterogeneous placebo rate of remission and the different statistical methods used to analyze the results. It is important that trials are designed efficiently, done well and complement clinical practice with a careful subject…

Lipid-lowering nutraceuticals in clinical practice: position paper from an International Lipid Expert Panel

2017

In recent years, there has been growing interest in the possible use of nutraceuticals to improve and optimize dyslipidemia control and therapy. Based on the data from available studies, nutraceuticals might help patients obtain theraputic lipid goals and reduce cardiovascular residual risk. Some nutraceuticals have essential lipid-lowering properties confirmed in studies; some might also have possible positive effects on nonlipid cardiovascular risk factors and have been shown to improve early markers of vascular health such as endothelial function and pulse wave velocity. However, the clinical evidence supporting the use of a single lipid-lowering nutraceutical or a combination of them is…

Comparison of piezosurgery and conventional rotary instruments in schneider’s membrane sinus lifting: A pilot randomized trial

2020

Background The present study aimed to evaluate and compare the postoperative effects of the piezoelectric device and conventional rotary instruments in Schneider’s membrane sinus lifting procedure. Material and Methods Twenty patients requiring bilateral maxillary bone graft augmentation in the posterior maxillary region were selected. Piezoelectric surgery was performed on one side and conventional surgery with a rotary diamond bur on the other. Postoperative pain, swelling, edema, and mouth opening were evaluated at one hour and two and seven days after the procedures. All variables were submitted to Friedman or Wilcoxon tests at a 5% significance level. Results The comparison between gro…

The diode laser as coadyuvant therapy in the non-surgical conventional treatment of peri-implant mucositis: A systematic review and meta-analysis

2020

Background The present study systematically reviewed randomized controlled trials (RCT) to investigate the effect of diode laser therapy in the management of peri-implant mucositis. Material and Methods The electronic databases were searched until January 2020. Outcome measures were bleeding on probing (BOP), plaque index (PI) and probing depth (PD). The addressed PICO question was: Is the diode laser therapy effective reducing the signs of inflammation as an adjunctive element in the non-surgical treatment of peri-implant mucositis?. Results Eight randomized clinical trials (RCTs) were included in the systematic review for qualitative synthesis and three in the meta-analysis for quantitati…