Active — Not RecruitingNot Applicable

Effects of Local Ketamine in Orthognathic Procedures

Turkey (Türkiye)40 participantsStarted 2025-06-21

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

rescue analgesia dose

Timeframe: 2 days

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

Timeframe: 7 days

Visual analogue scale

Timeframe: 2 days

Trial details

NCT IDNCT07066306

SponsorBezmialem Vakif University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-10

View on ClinicalTrials.gov More Dentofacial Deformities trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Effects of Local Ketamine in Orthognathic Procedures

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Effects of Local Ketamine in Orthognathic Procedures

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria