Dentofacial DeformitiesNCT07066306
Effects of Local Ketamine in Orthognathic Procedures
A study testing Ketamine and Articaine Hydrochloride + Epinephrine in people with Dentofacial Deformities and Analgesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dentofacial Deformities, Analgesia, Vomiting, Postoperative
- What is being tested?
- Ketamine and Articaine Hydrochloride + Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2025to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf Universty
Istanbul, Fatih, 34093
About this study
Official title: Evaluation of the Intraoperative and Postoperative Effects of Local Ketamine Injection in Orthognathic Surgery
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.
Read the detailed description
Orthognathic surgery is performed to correct congenital or developmental anomalies of the maxilla and mandible, as well as secondary deformities caused by trauma. These procedures require multiple incisions, dissections, and osteotomies in both the maxilla and mandible. The acute postoperative pain that follows orthognathic surgery is primarily the result of these surgical traumas and the subsequent inflammatory process. As tissue healing progresses, postoperative pain gradually subsides. This type of pain is one of the primary factors affecting postoperative recovery, return to function, and length of hospital stay.
Many studies have focused on achieving optimal analgesia during this period, which significantly affects patients' postoperative quality of life. For this purpose, several agents have been used, including non-steroidal anti-inflammatory drugs (NSAIDs), opioids, non-opioid analgesics (such as acetaminophen), NMDA receptor antagonists, and long-acting local anesthetics.
Ketamine is a well-known general anesthetic and short-acting intraoperative analgesic agent with established pharmacodynamic and pharmacokinetic profiles and known side effects. Ketamine is a non-selective antagonist of supraspinal N-methyl-D-aspartate (NMDA) receptors. It is believed that inhibition of these receptors reduces neuronal excitation and produces analgesia through this mechanism. Ketamine's interactions with spinal pain receptors and opioid receptors are also thought to contribute to its analgesic effects.
In low doses, ketamine has been evaluated for local analgesic purposes in combination with local anesthetics in various surgical procedures, aiming to minimize side effects. Cleft palate repair and third molar extractions are among the oral surgery procedures where the local analgesic efficacy of ketamine has been investigated. In a study by Jha et al. on cleft palate repair, the authors examined the effects of local bupivacaine combined with ketamine on postoperative nausea, vomiting, dysphagia, and sleep patterns. They found that patients in the ketamine group had superior outcomes in terms of reduced need for additional analgesia, improved sleep, and earlier return to feeding.
Similarly, in the literature some studies reported that significant reductions in postoperative pain, swelling, and trismus in third molar extraction patients when sub-anesthetic doses of ketamine were combined with local anesthetics. Shah et al. also observed that combining ketamine with local anesthetics during third molar extraction reduced postoperative pain and swelling compared to local anesthetics alone.
To date, there are no studies in the literature investigating the effects of combining ketamine with local anesthetics in orthognathic surgery. Therefore, this study was designed to address this gap.
- Being tested
- Ketamine, Articaine Hydrochloride + Epinephrine
- Keywords
- orthognthic surgery, ketamine, analgesia, nausea and vomiting
- Medical subject headings
- Dentofacial Deformities, Agnosia, Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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.
Articaine Hydrochloride + EpinephrineDrug
Also called local anesthetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ketamine |
| control group | Active comparator | Following induction of general anesthesia, standard local anesthetic (articaine) will be locally administered in this group Receives: Drug: Articaine Hydrochloride + Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 2 days
Secondary outcomes (1)
nausea and vomiting
after the operation investigator assess the nausea and vomiting every 2 hours interval and score it in 4 point scale
Nausea and Vomiting Scoring System:
0 = No nausea
- = Nausea only
- = Nausea accompanied by retching
- = Vomiting
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start21 Jun 2025
- Primary completion10 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066306
- Sponsor's protocol ID
- E-54022451
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intraoperative and Postoperative Effects of Local Ketamine Injection in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07066306
- Acronym / sponsor ID
- E-54022451
- Keywords
- orthognthic surgery, ketamine, analgesia, nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Orthognathic surgery is performed to correct congenital or developmental anomalies of the maxilla and mandible, as well as secondary deformities caused by trauma. These procedures require multiple incisions, dissections, and osteotomies in both the maxilla and mandible. The acute postoperative pain that follows orthognathic surgery is primarily the result of these surgical traumas and the subsequent inflammatory process. As tissue healing progresses, postoperative pain gradually subsides. This type of pain is one of the primary factors affecting postoperative recovery, return to function, and length of hospital stay.
Many studies have focused on achieving optimal analgesia during this period, which significantly affects patients' postoperative quality of life. For this purpose, several agents have been used, including non-steroidal anti-inflammatory drugs (NSAIDs), opioids, non-opioid analgesics (such as acetaminophen), NMDA receptor antagonists, and long-acting local anesthetics.
Ketamine is a well-known general anesthetic and short-acting intraoperative analgesic agent with established pharmacodynamic and pharmacokinetic profiles and known side effects. Ketamine is a non-selective antagonist of supraspinal N-methyl-D-aspartate (NMDA) receptors. It is believed that inhibition of these receptors reduces neuronal excitation and produces analgesia through this mechanism. Ketamine's interactions with spinal pain receptors and opioid receptors are also thought to contribute to its analgesic effects.
In low doses, ketamine has been evaluated for local analgesic purposes in combination with local anesthetics in various surgical procedures, aiming to minimize side effects. Cleft palate repair and third molar extractions are among the oral surgery procedures where the local analgesic efficacy of ketamine has been investigated. In a study by Jha et al. on cleft palate repair, the authors examined the effects of local bupivacaine combined with ketamine on postoperative nausea, vomiting, dysphagia, and sleep patterns. They found that patients in the ketamine group had superior outcomes in terms of reduced need for additional analgesia, improved sleep, and earlier return to feeding.
Similarly, in the literature some studies reported that significant reductions in postoperative pain, swelling, and trismus in third molar extraction patients when sub-anesthetic doses of ketamine were combined with local anesthetics. Shah et al. also observed that combining ketamine with local anesthetics during third molar extraction reduced postoperative pain and swelling compared to local anesthetics alone.
To date, there are no studies in the literature investigating the effects of combining ketamine with local anesthetics in orthognathic surgery. Therefore, this study was designed to address this gap.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local ketamine group | Experimental | Drug: KetamineFollowing induction of general anesthesia, 0.2 mg/kg of ketamine will be locally administered in place of standard local anesthetic in this group |
| control group | Active comparator | Drug: Articaine Hydrochloride + EpinephrineFollowing induction of general anesthesia, standard local anesthetic (articaine) will be locally administered in this group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineIn 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. | Drug | local ketamine group |
| Articaine Hydrochloride + EpinephrineAlso: local anestheticA 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. | Drug | control group |
Primary outcome
rescue analgesia dose
Time frame: 2 days
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).
postoperative edema calculation for the first 1-3 and 7 day (cm)
Time frame: 7 days
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.
Visual analogue scale
Time frame: 2 days
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.
1 secondary outcome
nausea and vomiting
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Articaine Hydrochloride + Epinephrine in people with Dentofacial Deformities and Analgesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rescue analgesia dose (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.