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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Other Surgical Procedures
• Intervention / Treatment: Drug: Ketoprofen; Drug: Ketoprofen and Omeprazole

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012-901
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Ketoprofen; Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.; Other Names: Lower third molar surgery with Ketoprofen
Experimental: 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	Drug: Ketoprofen and Omeprazole; Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.; Other Names: Lower third molar surgery with Ketoprofen and Omeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation of postsurgical pain	Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) at the fourth postoperative hour.	Fourth postoperative hour
Quality of anesthesia during surgery based on a category 3point scale	Quality of anesthesia during surgery based on a category 3point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.	During the surgical procedure
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale	Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale (1 minimal bleeding; 2 normal bleeding; 3 excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.	During the surgical procedure
Heart rate	Median heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters	During the surgical procedure
Oxygen saturation	Median oxygen saturation recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.	During the surgical procedure
Systolic blood pressure	Median systolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters	During the surgical procedure
Diastolic blood pressure	Median diastolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters	During the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws	Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws was measured and recorded before the surgery and during the second and seventh postoperative days.	Second and Seventh postoperative days
Onset and duration of surgery after administration of anesthetic	Will only be considered those surgeries in which there is no long time gap between the two surgical times.	During the surgery
Incidence, type and severity of adverse reactions	Will be considered as adverse reactions: gastrointestinal irritation, nausea, vomiting, bleeding, allergy, headache, dizziness, drowsiness or any other type of reaction presented after surgery.	Seventh postoperative day
Total amount of rescue medication	The total amount of rescue medication that was used by the patient during the postoperative period (paracetamol 750 mg) will be analyzed	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.	It will apply the method used by Ustun et al. (2003), which takes into account the sum of the following measures (obtained with flexible tape measure): A) distance between the lateral corner of the eye and the gonion, B) away from the tragus corner of the mouth and C) away from the tragus to the soft tissue of pogonion. Preoperative sum of three measures will be considered as the baseline that way. The difference between the values obtained in the postoperative period and baseline indicate the facial edema in the 2nd and 7th days.	On the second day after surgery and on the seventh day after surgery

Collaborators and Investigators

• Sponsor: Luis Fernando Simoneti
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Luis Fernando Simoneti, DDS, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Omeprazole; Oral Surgery; Ketofrofen; Lower Third Molar
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole; Ketoprofen
• Other Study ID Numbers: 44808215.6.0000.5417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided