Overview

This trial is active, not recruiting.

Conditions pain, other surgical procedures
Treatments ketoprofen, ketoprofen and omeprazole
Phase phase 4
Sponsor Luis Fernando Simoneti
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date June 2015
End date December 2016
Trial size 50 participants
Trial identifier NCT02730026, 44808215.6.0000.5417

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Fifty healthy volunteers underwent removal one of lower third molar, will be treated to control pain, swelling and trismus with ketoprofen 100 mg
ketoprofen Lower third molar surgery with Ketoprofen
Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.
(Experimental)
Fifty healthy volunteers underwent removal the other lower third molars, will be treated to control pain, swelling and trismus with ketoprofen 200 mg associated with Omeprazole 20 mg
ketoprofen and omeprazole Lower third molar surgery with Ketoprofen and Omeprazole
Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.

Primary Outcomes

Measure
Subjective evaluation of postsurgical pain
time frame: Fourth postoperative hour
Quality of anesthesia during surgery based on a category 3point scale
time frame: During the surgical procedure
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale
time frame: During the surgical procedure
Heart rate
time frame: During the surgical procedure
Oxygen saturation
time frame: During the surgical procedure
Systolic blood pressure
time frame: During the surgical procedure
Diastolic blood pressure
time frame: During the surgical procedure

Secondary Outcomes

Measure
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws
time frame: Second and Seventh postoperative days
Onset and duration of surgery after administration of anesthetic
time frame: During the surgery
Incidence, type and severity of adverse reactions
time frame: Seventh postoperative day
Total amount of rescue medication
time frame: Seventh postoperative day
Measurement the facial edema distance between the lateral corner of the eye and the gonion, away from the tragus corner of the mouth and away from the tragus to the soft tissue of pogonion.
time frame: On the second day after surgery and on the seventh day after surgery

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - Need of lower third molar surgeries in similar positions Exclusion Criteria: - Presence of systemic diseases; - Presence of local inflammation and/or infection; - Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration; - Cardiovascular, kidney or hepatic diseases; - Patients who are making use of antidepressants, diuretics or anticoagulants; - Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug; - Regular use of any nonsteroidal antiinflammatory drug, pregnancy or breast feeding.

Additional Information

Official title Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal
Principal investigator Luis Fernando Simoneti, DDS
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.