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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
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.
Details
| Lead sponsor | Giovana Maria Weckwerth |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2014-10 |
| Completion | 2016-03 |
Conditions
- Pain
- Other Surgical Procedures
- Impacted Third Molar Tooth
Interventions
- Surgery with Naproxen
- Surgery with Naproxen and Esomeprazole
Primary outcomes
- Evaluation of postsurgical pain — Seventh postoperative day
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 \[0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h\]. - Quality of anesthesia — 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. - Intraoperative bleeding — 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. - Blood pressure — During the surgical procedure
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. - Heart rate — During the surgical procedure
Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters. - Oxygen saturation — During the surgical procedure
Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Countries
Brazil