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

NCT05923775 | Unknown

• 1 other identifier: 2021/197
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Molar, Third

Keywords

pain; trismus; analgesia; ketamine; Ibuprofen

Outcome Measures

Primary Outcomes (7)

• 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].

• 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].

• 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].

• 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].

• 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].

• 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].

• 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 Outcomes (1)

• The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.

  The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.

Study Arms (4)

Intrafen group

ACTIVE COMPARATOR

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, each patient in this group will be given 2 ml of local anesthesia.

Procedure: Impacted third molar surgey

Ketamine group

ACTIVE COMPARATOR

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, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.

Procedure: Impacted third molar surgey

Combined group (Intrafen+Ketamine)

ACTIVE COMPARATOR

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 surgery, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia.

Procedure: Impacted third molar surgey

Control

PLACEBO COMPARATOR

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, each patient in this group will be given 2 ml of local anesthesia.

Procedure: Impacted third molar surgey

Interventions

Impacted third molar surgey PROCEDURE

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.

Combined group (Intrafen+Ketamine); Control; Intrafen group; Ketamine group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cihan Topan: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, (0352) 438 06 57, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Trismus; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Central Study Contacts

Cihan Topan, Doctor

CONTACT

05556456587; cihantopan@hotmail.com

Suheyb Bilge, Doctor

CONTACT

05302112349; suheybbilge@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor, Principal Investigator, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 28, 2023
• Study Start: March 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)