Effects of Local Ketamine in Orthognathic Procedures

NCT07066306 | Active Not Recruiting

• 1 other identifier: E-54022451
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Orthognathic surgery is performed to correct congenital, developmental, or trauma-related skeletal deformities of the maxilla and mandible. These procedures involve multiple incisions, dissections, and osteotomies, leading to significant postoperative inflammatory responses and acute pain. Postoperative pain is a key factor influencing recovery, return to function, and length of hospital stay. Various analgesics have been used to manage pain after orthognathic surgery, including NSAIDs, opioids, acetaminophen, NMDA receptor antagonists, and long-acting local anesthetics. Ketamine is a well-known NMDA receptor antagonist with both central and peripheral analgesic effects. In subnesthetic doses, ketamine has been evaluated in various surgical fields for its potential to enhance analgesia when combined with local anesthetics, while minimizing systemic side effects. Studies have shown that local ketamine administration during cleft palate repair and third molar extractions can significantly reduce postoperative pain, swelling, and trismus. However, to date, no studies have investigated the effects of locally administered ketamine in orthognathic surgery. Therefore, this study was designed to evaluate the intraoperative and postoperative effects of local ketamine injection in this context.

Conditions

Dentofacial Deformities; Analgesia; Vomiting, Postoperative; Nausea, Postoperative

Keywords

orthognthic surgery; ketamine; analgesia; nausea and vomiting

Outcome Measures

Primary Outcomes (3)

• rescue analgesia dose

  In the postoperative period, in addition to the standard pain management protocol, the need for rescue analgesia will be recorded by calculating the total administered dose. For rescue analgesia, 50 mg of tramadol will be delivered via infusion pump and administered through patient-controlled analgesia (PCA).

  2 days

• postoperative edema calculation for the first 1-3 and 7 day (cm)

  the first secondary outcome of this study is post operative edema: Prior to anesthesia induction, Tragus (Tra) and Gonion (Go) points were marked with methylene blue, and distances including Lateral Canthus - Gonion, Tragus-Commissure, and interincisal distances were measured with a paper ruler and recorded as preoperative measurements.Measurements of Lateral Canthus - Gonion, Tragus-Commissure, and Interincisal distances were repeated on postoperative days 1, 3, and 7 for evaluating postoperative edema.

  7 days

• Visual analogue scale

  Author asses the pain score with visual analogue scale (VAS) every 2 hours interval with 2. days. Higher scores means patients feel more pain and lower scores mean patients feel low pain. minımum score is 0, and maximum is 100.

  2 days

Secondary Outcomes (1)

• nausea and vomiting

  3 days

Study Arms (2)

local ketamine group

EXPERIMENTAL

Following induction of general anesthesia, 0.2 mg/kg of ketamine will be locally administered in place of standard local anesthetic in this group

Drug: Ketamine

control group

ACTIVE COMPARATOR

Following induction of general anesthesia, standard local anesthetic (articaine) will be locally administered in this group

Drug: Articaine Hydrochloride + Epinephrine

Interventions

Ketamine DRUG

In the ketamine group, 0.2 mg/kg of ketamine will be administered locally. This application will be performed twice: once during the Le Fort I osteotomy and once during the sagittal split osteotomy. After calculating the total dose, it will be equally divided and administered locally to both the maxilla and the mandible.

local ketamine group

Articaine Hydrochloride + Epinephrine DRUG

A total of 4 ampoules of articaine hydrochloride will be used. Two ampoules will be administered prior to the incision during the Le Fort I osteotomy, and the remaining two ampoules will be used prior to the incision during the sagittal split osteotomy.

Also known as: local anesthetic

control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Class II or Class III skeletal deformities who underwent bimaxillary orthognathic surgery due to dentofacial deformities.
• ASA I-II physical status patients.
• Patients aged between 18 and 45 years.
• Patients who received anesthesia induction and maintenance with propofol (0.2-0.6 mg/kg/hour) titrated to maintain an entropy score between 40-60, and remifentanil (0.05-0.5 mg/kg/hour) adjusted to maintain a Surgical Pleth Index (SPI) between 20-50.
• Patients who received a combination of local anesthetic and ketamine.
• Patients who were administered patient-controlled analgesia (PCA) at the end of the surgery and whose opioid consumption via PCA was monitored during the first 24 hours postoperatively.
• Patients whose nausea-vomiting scores and need for antiemetics were recorded.
• Patients with complete documentation of anesthesia records, including entropy scores, SPI values, and total doses of propofol and remifentanil administered.
• Patients with completed postoperative edema follow-up forms.

You may not qualify if:

• Patients with a known allergy to ketamine.
• Patients with uncontrolled systemic diseases.
• Patients using psychotropic medications.
• Patients with a history of substance abuse.
• Patients with chronic pain lasting longer than 3 months.
• Patients using analgesic or hypnotic medications for more than 2 weeks.
• Cases in which complications occurred during surgery that required deviation from the standard orthognathic surgical protocol and could potentially affect postoperative pain levels (e.g., bad split, unexpectedly prolonged surgical duration, etc.).

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentofacial Deformities; Agnosia; Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Ketamine; Carticaine; Epinephrine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 15, 2025
• Study Start: June 21, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)