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
Verified date | November 2016 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo | Bauru | SP |
Lead Sponsor | Collaborator |
---|---|
Giovana Maria Weckwerth | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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 |
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