A Phase 4 interventional study of Surgery with Naproxen and Surgery with Naproxen and Esomeprazole in Pain, Other Surgical Procedures and Impacted Third Molar Tooth, sponsored by Giovana Maria Weckwerth. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Giovana Maria Weckwerth · Phase 4, Interventional, and Supportive care
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.
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.
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This study's enrollment of 50 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg.
Drug: Surgery with Naproxen
Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg and esomeprazole 20mg.
Drug: Surgery with Naproxen and Esomeprazole
Drug page: Naproxen
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.
Also known as: Lower third molar surgery with Naproxen
Drug pages: Naproxen · Esomeprazole
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.
Also known as: Lower third molar surgery with Naproxen and Esomeprazole
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 \[0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h\].
Time frame: Seventh postoperative day
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.
Time frame: During the surgical procedure
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.
Time frame: During the surgical procedure
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.
Time frame: During the surgical procedure
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.
Time frame: During the surgical procedure
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.
Time frame: During the surgical procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Seventh postoperative day
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.
Time frame: On the second day after surgery and on the seventh day after surgery.
Plan to share: No
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The record gives a start of Oct 2014, a primary completion of Dec 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Naproxen · Esomeprazole