NCT05923775

Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination

Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cihan Topan · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery?

Detailed description

Materials and methods The study will comprise 100 individuals who requested to have their mandibular third molar tooth extracted at the Erciyes University Faculty of Dentistry. Participants were randomly allocated into four groups, with 25 patients in each group. The first group (Intrafen group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed. The second group (Ketamine group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed. The third group (Combined group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed. The fourth group (Control group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.

Conditions

• Molar, Third

Interventions

Type	Name	Description
PROCEDURE	Impacted third molar surgey	The surgery was performed using the classic technique: ten minutes after anesthesia administration, a horizontal and sulcular incision was performed, and a mucoperiosteal envelope flap was elevated. The bone covering the impacted third molar tooth was removed with the use of a surgical handpiece and rotary instrument. During the operation, saline water was applied to the surgical drill with a second hand to protect the bone from developing a high temperature. After extraction of the third molar, the cavity was treated with curettage, irrigated with saline, and sutured.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2023-06-28
• Last updated: 2023-09-07

Locations

1 site across 1 country: Turkey (Türkiye)