scholarly journals Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
R. Andrew Moore ◽  
Sheena Derry
Keyword(s):  
Cochrane Review ◽  
Third Molar ◽  
Gynaecological Surgery ◽  
Acute Postoperative Pain ◽  
Double Blind ◽  
Third Molar Extraction ◽  
Maximum Pain ◽  
Numbers Needed To Treat ◽  
Study Designs ◽  
Clinical Study Reports

We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness.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.

scholarly journals Third Molar Extraction: Irrigation and Cooling with Water or Sterile Physiological Solution: A Double-Blind Randomized Study

2021 ◽  
Vol 9 (4) ◽  
pp. 40
Author(s):  
Luca Sbricoli ◽  
Alessia Cerrato ◽  
Anna Chiara Frigo ◽  
Gastone Zanette ◽  
Christian Bacci
Keyword(s):  
Postoperative Pain ◽  
Randomized Study ◽  
Third Molar ◽  
Physiological Solution ◽  
Wilcoxon Test ◽  
University Hospital ◽  
Double Blind ◽  
Third Molar Extraction ◽  
Surgical Field ◽  
Molar Extraction

Background: The present study aimed to ascertain whether any significant reduction in patients’ postoperative pain and inflammation could be achieved by using sterile physiological solution instead of normal water to irrigate the surgical field and cool the dental bur during third molar extractions. Methods: The study concerned 22 patients (11 females and 11 males) in good general health, who were referred to the Dental Clinic at Padova University hospital for lower third molar extractions. They were randomly assigned to two groups. Only the fluid used to irrigate the surgical field and cool the dental bur differed between the two study groups, being sterile physiological solution for group A, and mains water for group B. Postoperative pain, swelling, trismus and inflammation with high sensitivity CRP where measured and statistically evaluated. The numerosity of our sample was calculated on the grounds of an endpoint based on data in the literature. Results: Eighteen patients needed bilateral extractions, and 4 required only one extraction, so a total of 40 third molars were extracted. A sterile physiological solution was used to irrigate the surgical field in 20 extractions, while water was used in the other 20 cases. Data analysis with Wilcoxon test show no differences between the two groups (p < 0.05). Conclusions: no differences between groups for any of the parameters considered, after third molar extraction procedures undertaken using either sterile physiological solution or water for irrigation and cooling purposes.

Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction

2018 ◽  
Vol 22 (9) ◽  
pp. 2981-2988 ◽  
Author(s):  
Maria Victoria Olmedo-Gaya ◽  
Francisco Javier Manzano-Moreno ◽  
Jose Luis Muñoz-López ◽  
Manuel Francisco Vallecillo-Capilla ◽  
Candela Reyes-Botella
Keyword(s):  
Clinical Trial ◽  
Local Anesthetics ◽  
Third Molar ◽  
Analgesic Efficacy ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Impacted Third Molar ◽  
Randomized Controlled ◽  
Third Molar Extraction

scholarly journals A Double-Blind Placebo-Controlled Comparison of a Novel Formulation of Intravenous Diclofenac and Ketorolac for Postoperative Third Molar Extraction Pain

2011 ◽  
Vol 58 (2) ◽  
pp. 73-81 ◽  
Author(s):  
Kyle Christensen ◽  
Stephen Daniels ◽  
Donald Bandy ◽  
Cynthia C. Ernst ◽  
Douglas A. Hamilton ◽  
...  
Keyword(s):  
Pain Relief ◽  
Pain Intensity ◽  
Third Molar ◽  
Global Evaluation ◽  
Onset Of Action ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Molar Extraction ◽  
Secondary Endpoints ◽  
Molar Extraction

Abstract Dyloject is a novel formulation of diclofenac intended for intravenous (IV) administration. This formulation employs the solubilizing agent hydroxypropyl-β-cyclodextrin to permit bolus IV administration. The efficacy and safety of 5 dose levels of IV diclofenac were compared with IV ketorolac and placebo following third molar extraction. This was a single-dose, randomized, double-blind, placebo- and comparator-controlled, parallel-group study. A total of 353 subjects with moderate to severe pain received placebo; ketorolac 30 mg; or IV diclofenac 3.75, 9.4, 18.75, 37.5, or 75 mg (N  =  51 for all groups, except N  =  47 for ketorolac). The primary endpoint was total pain relief over 6 hours (TOTPAR6) as measured by the visual analog scale (VAS). Secondary endpoints included multiple measures of pain intensity and relief; patient global evaluation; and times to pain relief and rescue medication. Dropouts and adverse effects (AEs) were also monitored. IV diclofenac was superior to placebo as measured by TOTPAR6 (P &lt; .0001 for all doses except 3.75 mg, for which P  =  .0341). IV diclofenac 3.75 mg was statistically superior to placebo for TOTPAR2 and TOTPAR4. IV diclofenac at both 37.5 and 75 mg was superior to placebo (P &lt; .05) at the earliest (5 minute) assessments of pain intensity and pain relief, but ketorolac was not. The proportion of patients reporting 30% or greater pain relief at 5 minutes was significantly greater after IV diclofenac 37.5 and 75 mg than after ketorolac 30 mg or placebo. Secondary endpoints confirmed the primary findings. Treatment-related AEs were generally mild to moderate and were typical for nonsteroidal anti-inflammatory drugs (NSAIDs). The more rapid onset of action of IV diclofenac compared with the reference injectable NSAID ketorolac suggests additional clinical benefit. If confirmed in larger series, these findings may improve the safety and efficacy of postoperative NSAID analgesia.

scholarly journals Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period

2014 ◽  
pp. e157-e162 ◽  
Author(s):  
MC. de la Barrera-Nunez ◽  
RM. Yanez-Vico ◽  
A. Batista-Cruzado ◽  
JM. Heurtebise-Saavedra ◽  
R. Castillo-de Oyague ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Period ◽  
Third Molar ◽  
Double Blind ◽  
The Third ◽  
Third Molar Extraction ◽  
Double Blind Clinical Trial ◽  
Molar Extraction
Sign in / Sign up

Export Citation Format

Share Document