Evaluation of the efficiency of different schemes of pre operative analgesia in oral surgeries

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: E03.091 The objective is to compare the efficacy of preemptive analgesia protocols in periodontal surgeries and dental implant surgeries. For periodontal surgeries, groups will be (n per group = 25): Group 1 ‐ Paracetamol 750 mg (Tylenol® Johnson & Johnson do Brasil Ltda); Group 2 ‐ Ibuprofen 600 mg (Alivium® MANTECORP Indústria Química e Farmacêutica Ltda.); Group 3 ‐ Ketoprofen 100 mg (Profenid® Sanofi‐Aventis Farmacêutica Ltda) Group 4 ‐ Nimesulide 100 mg (Cimelide® CIMED Indústria de Medicamentos Lltda.); Group 5 ‐ Dexamethasone 4 mg (Decadron® Aché Laboratories Farm, S.A); Group 6 ‐ Placebo. The method to choose the patient who will receive the medication will be through a sequential lottery. In the first group, patients will receive 1 tablet of Paracetamol (Tylenol® 750mg) orally every 8 hours 24 hours before surgery. In the second group, patients will receive 1 Ibuprofen tablet (Alivium® 600 mg) orally every 8 hours 24 hours before surgery. In the third group, patients will receive 1 tablet of ketoprofen (Profenid® 100mg) orally every 12 hours 24 hours before surgery. In the fourth group, patients will receive 1 tablet of Nimesulide (Cimelide® 100mg) orally every 12 hours 24 hours before surgery. In the fifth group, patients will receive 1 Dexamethasone tablet (Decadron® 4mg) orally 24 hours before surgery. In the sixth group, patients will receive a placebo, a capsule containing corn starch, orally every 8 hours at the same dosage. In case of post‐surgical pain, patients will be instructed to take the indicated rescue medication (Tylenol® 750 mg). For dental implant surgeries, groups will be (n per group = 25): Group 1 ‐ Paracetamol 750 mg (Tylenol® Johnson & Johnson do Brasil Ltda); Group 2 ‐ Ibuprofen 600 mg (Alivium® MANTECORP Indústria Química e Farmacêutica Ltda.); Group 3 ‐ Placebo. The method to choose the patient who will receive the medication will be through a sequential lottery. In the first group, patient CONDITION: C07.465.714 E03.091 E04.545 E04.545.550.280 preemptive analgesia; oral surgeries; open flap periodontal surgeries; dental implant surgeries ; C07.465.714 ; E04.545.550.280 ; E03.091 ; E04.545 PRIMARY OUTCOME: Intensity of post operative pain, evaluated through visual analogic scale (VAS) from 0 to 10 points after 1 hour, 6 hours, 12 hours, 24 hours, 48 hours, and 1 week post surgery. SECONDARY OUTCOME: Amount of rescue drug used evaluated through the amount of pills used and the days when used. Post operative edema, evaluated through 2 facial measures in centimeters, from tragus ‐ nose wing and tragus ‐ chin, evatualed after 1 hour, 6 hours, 12 hours, 24 hours, 48 hours, and 1 week post surgery. INCLUSION CRITERIA: for periodontal surgeries patients with periodontitis and need for open flap periodontal surgery for scaling and root planing; patients with good systemic health ASA I or II who do not make continuous use of any analgesic and anti‐inflammatory medication that could bring some kind of bias to the study outcomes; patients with absence of pain; for dental implant surgeries patients with need of bone‐integrated dental implant diameter 3.5 mm or 3.75 mm height 10 or 13 mm with the site presenting 2 mm of keratinized gingiva and 10 mm of vertical bone and more than 5 mm of vestibular‐lingual bone; patients with good systemic health ASA I or II who do not make continuous use of any analgesic and anti‐inflammatory medication that could bring some kind of bias to the study outcomes; patients with absence of pain and signs of oral infection.
Epistemonikos ID: 2b7b3fc815089ed7bc1fb433eda88004005c485d
First added on: Aug 24, 2024