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Completed

NCT Number: NCT02730026

Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole 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.

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Key information

Conditions

Pain Neurologic Manifestations Other Surgical Procedures Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo

Bauru, São Paulo, 17012-901, Brazil

About this study

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:

  • subjective postoperative pain evaluation, with the aid of a visual analogue scale,
  • mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal),
  • beginning and duration of the surgery after anesthetic administration,
  • incidence, type and severity of adverse reactions,
  • total amount of rescue analgesic medication (paracetamol),
  • facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketoprofen

Drug

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

Other names: Lower third molar 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.

Other names: Lower third molar surgery with Ketoprofen and Omeprazole

Primary outcomes

  1. Subjective evaluation of postsurgical pain

    Time frame: Fourth postoperative hour

    Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) at the fourth postoperative hour.

  2. Quality of anesthesia during surgery based on a category 3point scale

    Time frame: During the surgical procedure

    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.

  3. Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale

    Time frame: During the surgical procedure

    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.

  4. Heart rate

    Time frame: During the surgical procedure

    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

  5. Oxygen saturation

    Time frame: During the surgical procedure

    Median oxygen saturation recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

  6. Systolic blood pressure

    Time frame: During the surgical procedure

    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

  7. Diastolic blood pressure

    Time frame: During the surgical procedure

    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

Secondary outcomes

  1. 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

    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.

  2. Onset and duration of surgery after administration of anesthetic

    Time frame: During the surgery

    Will only be considered those surgeries in which there is no long time gap between the two surgical times.

  3. Incidence, type and severity of adverse reactions

    Time frame: Seventh postoperative day

    Will be considered as adverse reactions: gastrointestinal irritation, nausea, vomiting, bleeding, allergy, headache, dizziness, drowsiness or any other type of reaction presented after surgery.

  4. Total amount of rescue medication

    Time frame: Seventh postoperative day

    The total amount of rescue medication that was used by the patient during the postoperative period (paracetamol 750 mg) will be analyzed

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Luis Fernando Simoneti

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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