Submucosal diclofenac for acute postoperative pain in third molar surgery: A randomized, controlled clinical trial

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)

Quality of life of patients after cardiac surgery participating in the rehabilitation program

Schorzenia układu sercowo-naczyniowego stanowią główną przyczynę zgonów mężczyzn po 45 roku życia i kobiet po 65 roku życia. Celem pracy była ocena jakości życia (QoL - quality of life) pacjentów po zabiegach kardiochirurgicznych, poddanych poszpitalnej rehabilitacji kardiologicznej. Do badań zakwalifikowano 64 osoby (48 mężczyzn i 16 kobiet), w wieku od 40 do 82 lat. Badane osoby zostały podzielone na dwie grupy: Grupa A - pacjenci po zabiegach kardiochirurgicznych w krążeniu pozaustrojowym, 36 osób (56,25% badanych) oraz grupa B - pacjenci po zabiegach kardiochirurgicznych, przeprowadzonych bez krążenia pozaustrojowego, 28 osób (43,75% badanych). Jakość życia była oceniana przed i po 21-dniowym turnusie wczesnej rehabilitacji kardiologicznej. Do badania jakości życia zastosowano wystandaryzowany kwestionariusz ogólny The World Health Organization Quality of Life BREF (WHOQoL-BREF) oraz kwestionariusz MacNew, przeznaczony do oceny QoL w przypadku schorzeń kardiologicznych. Przeprowadzone analizy wykazały, że udział w rehabilitacji kardiologicznej poprawia jakość życia pacjentów po zabiegach kardiochirurgicznych.Cardiovascular lesions belong to the main death causes in men in age over 45 years and women over 65 years old. The aim of the study was to assess the quality (QoL) of life of patients after cardiac surgery that were exposed to the early stage cardiac rehabilitation. 64 persons (48 men and 16 women), aged from 40 to 82 years, were enrolled into the study. The subjects were divided into two groups: Group A - patients after cardiosurgical procedures performed in the extracorporeal circulation,- 36 people (56.25% of respondents) and group B - patients after cardiac surgery with no extracorporeal circulation, 28 people (43.75% of respondents). The quality of life was assessed before and after the 21 days of early cardiac rehabilitation. The standardized general questionnaire of The World Health Organization: Quality of Life BREF (WHOQoL-BREF) and MacNew questionnaire, specific to the cardiovascular diseases, were used to asses the quality of life. The analysis carried out show that active participation in cardiac rehabilitation improves the quality of life of patients after cardiac surgery