Clinical trial NCT05923775: Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination
Official title: Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Molar, Third
Keywords: pain
trismus
analgesia
ketamine
Ibuprofen
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2023-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 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, and ketamine
* Pregnant or breastfeeding patients
* Patients who have recently used a different group of NSAIDs for a different condition

Primary outcomes:
measure: The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
timeFrame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) two hours following impacted third molar surgery. [All study participants were asked to record their pain levels two hours after surgery].
measure: The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
timeFrame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) six hours following impacted third molar surgery. [All study participants were asked to record their pain levels six hours after surgery].
measure: The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
timeFrame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 12 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 12 hours after surgery].
measure: The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
timeFrame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 24 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 24 hours after surgery].
measure: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
timeFrame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded before surgery].
measure: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
timeFrame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded two days after the surgery].
measure: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
timeFrame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded seven days after the surgery].
Secondary outcomes:
measure: The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.
timeFrame: The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Dentistry
Study officials:
References: