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

NCT02730026 | Completed Phase 4 DMC

• 1 other identifier: 44808215.6.0000.5417
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Other Surgical Procedures

Keywords

Ketofrofen; Omeprazole; Lower Third Molar; Oral Surgery

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws

  Second and Seventh postoperative days

• Onset and duration of surgery after administration of anesthetic

  During the surgery

• Incidence, type and severity of adverse reactions

  Seventh postoperative day

• Total amount of rescue medication

  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.

  On the second day after surgery and on the seventh day after surgery

Study Arms (2)

Surgery with Ketoprofen

EXPERIMENTAL

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

Surgery with Ketoprofen and Omeprazole

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

Drug: Ketoprofen and Omeprazole

Interventions

Ketoprofen DRUG

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

Also known as: Lower third molar surgery with Ketoprofen

Surgery with Ketoprofen

Ketoprofen and Omeprazole DRUG

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

Also known as: Lower third molar surgery with Ketoprofen and Omeprazole

Surgery with Ketoprofen and Omeprazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Need of lower third molar surgeries in similar positions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luis Fernando Simoneti: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Ketoprofen; Omeprazole

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Luis Fernando Simoneti, DDS

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: April 6, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

BR (1)