Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal
Condition: Pain; Other Surgical Procedures
Study type: Interventional
Phase: Phase 4

Summary: 
      The control of pain, swelling and trismus in patients undergoing oral and maxillofacial
      surgery is frequently performed through the administration of non-steroidal anti-inflammatory
      drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and
      crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and
      ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg
      omeprazole) in 50 patients aged 18 years or older that require removal of both lower third
      molars symmetrically positioned. After collection, data will be analyzed by means of graphs
      and tables to allow the appropriate analyses. Paired t-test will be used to compare the
      duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue
      medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening"
      and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed
      by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results
      will be presented as mean ± standard deviation of the mean.
    

Detailed description: 
      Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of
      cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production
      whose effects potentiate the action of many inflammatory mediators. The protocol for the
      administration of these formulations will involve the administration of a tablet of the
      immediate release product (100 mg) every 12 hours, and one capsule of the modified release
      product (200 mg ketoprofen with omeprazole) every 24 hours, during 4 days.

      The following parameters will be analyzed:

        1. subjective postoperative pain evaluation, with the aid of a visual analogue scale,

        2. mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of
           suture removal),

        3. beginning and duration of the surgery after anesthetic administration,

        4. incidence, type and severity of adverse reactions,

        5. total amount of rescue analgesic medication (paracetamol),

        6. facial swelling measured on the 2nd and 7th postoperative days (in comparison with the
           measurements before the surgery).
    

Intervention name(s): Ketoprofen; Ketoprofen and Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.; Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.
Other intervention name(s): Lower third molar surgery with Ketoprofen; Lower third molar surgery with Ketoprofen and Omeprazole
Intervention MeSH terms: Ketoprofen; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Ketofrofen; Omeprazole; Lower Third Molar; Oral Surgery