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

Last updated: September 5, 2023
Sponsor: Cihan Topan
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Impacted third molar surgey

Clinical Study ID

NCT05923775
2021/197
  • Ages 18-25
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a fully embedded third molar tooth in the mandible
  • Patients with regular attendance for routine follow up
  • Patients with a healthy general systemic condition

Exclusion

Exclusion Criteria:

  • Patients with a fully erupted or partially embedded third molar tooth in the mandible
  • Patients who have previously experienced allergies to NSAIDs, local anesthetics, andketamine
  • Pregnant or breastfeeding patients
  • Patients who have recently used a different group of NSAIDs for a different condition

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Impacted third molar surgey
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
September 15, 2023

Study 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.

Connect with a study center

  • Erciyes University Faculty of Dentistry

    Kayseri, (0352) 438 06 57
    Turkey

    Active - Recruiting

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