Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal

Pain Clinical Trial

Official title:

Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494856
• Other study ID #: CAAE: 30317314.4.0000.5417
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2015
• Last updated: November 3, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.

Description:

The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory drugs (NSAIDS). 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 present study aims to evaluate in a double blind, randomized and cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. 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). The comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both NSAIDS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Other Surgical Procedures
• Pain
• Tooth, Impacted

Intervention

Drug:
• Surgery with Naproxen
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.
• Surgery with Naproxen and Esomeprazole
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.

Locations

Country	Name	City	State
Brazil	University of São Paulo	Bauru	SP

Sponsors (2)

Lead Sponsor	Collaborator
Giovana Maria Weckwerth	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of postsurgical pain	Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) and total amount (mg) of rescue medication consumption in the postoperative period. The subjective pain evaluations will be performed by patients at the following times after administration of the drugs [0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h].	Seventh postoperative day	Yes
Primary	Quality of anesthesia	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	Yes
Primary	Intraoperative bleeding	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	Yes
Primary	Blood pressure	Systolic blood pressure, diastolic, and mean 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	Yes
Primary	Heart rate	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	Yes
Primary	Oxygen saturation	Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.	During the surgical procedure	Yes
Secondary	Postoperative mouth opening	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Measurement the facial edema	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.	Yes