Clinical trial NCT02730026: Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Other Surgical Procedures
Keywords: Ketofrofen
Omeprazole
Lower Third Molar
Oral Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Subjective evaluation of postsurgical pain
timeFrame: Fourth postoperative hour
measure: Quality of anesthesia during surgery based on a category 3point scale
timeFrame: During the surgical procedure
measure: Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale
timeFrame: During the surgical procedure
measure: Heart rate
timeFrame: During the surgical procedure
measure: Oxygen saturation
timeFrame: During the surgical procedure
measure: Systolic blood pressure
timeFrame: During the surgical procedure
measure: Diastolic blood pressure
timeFrame: 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
timeFrame: Second and Seventh postoperative days
measure: Onset and duration of surgery after administration of anesthetic
timeFrame: During the surgery
measure: Incidence, type and severity of adverse reactions
timeFrame: Seventh postoperative day
measure: Total amount of rescue medication
timeFrame: Seventh postoperative day
measure: 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.
timeFrame: On the second day after surgery and on the seventh day after surgery
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Luis Fernando Simoneti, DDS
role: PRINCIPAL_INVESTIGATOR
References: