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Effects of Local Ketamine in Orthognathic Procedures

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 27, 2026 (before its estimated August 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 10, 2025 to Aug 10, 2026
    • Study completion date: Dec 25, 2025 to Aug 25, 2026
    v3
  2. Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07066306
Lead Sponsor Bezmialem Vakif University
Conditions
(from sponsor)		 Dentofacial Deformities, Analgesia, Vomiting, Postoperative, Nausea, Postoperative
Related terms Agnosia, Dentofacial Deformities, Nausea, Postoperative Nausea and Vomiting, Vomiting
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov