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

Molar, Third Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923775
• Other study ID #: 2021/197
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: TC Erciyes University
• Contact: Cihan Topan, Doctor
• Phone: 05556456587
• Email: cihantopan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Molar, Third
• Trismus

Intervention

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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Dentistry	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
Cihan Topan	TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.	VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)	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].
Primary	The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.	VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)	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].
Primary	The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.	VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)	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].
Primary	The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.	VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)	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].
Primary	The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.	Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.	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].
Primary	The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups	Trismus was evaluated on the second day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.	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].
Primary	The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups	Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.	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	The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.	All study participants will record the dose of rescue analgesic medicine (Paracetamol 500 mg) at home if they need to take it within 24 hours following surgery.	The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.