Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal

NCT ID: NCT02730026

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-03-31

Brief 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).

Conditions

Pain; Other Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Surgery with Ketoprofen

Fifty healthy volunteers underwent removal one of lower third molar, will be treated to control pain, swelling and trismus with ketoprofen 100 mg

Group Type: EXPERIMENTAL

Ketoprofen

Intervention Type: DRUG

Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.

Surgery with Ketoprofen and Omeprazole

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

Group Type: EXPERIMENTAL

Ketoprofen and Omeprazole

Intervention Type: DRUG

Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.

Interventions

Ketoprofen

Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.

Intervention Type: DRUG

Ketoprofen and Omeprazole

Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.

Intervention Type: DRUG

Other Intervention Names

Lower third molar surgery with Ketoprofen; Lower third molar surgery with Ketoprofen and Omeprazole

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Luis Fernando Simoneti

OTHER

Sponsor Role: lead

Responsible Party

Luis Fernando Simoneti

DDS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luis Fernando Simoneti, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

Bauru, São Paulo, Brazil

Countries

Brazil

Other Identifiers

44808215.6.0000.5417

Identifier Type: -

Identifier Source: org_study_id