AnesthesiaPhase 1NCT06867068
Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
A Phase 1 study testing Midazolam Hydrochloride, Fentanyl and Ketamine in people with Anesthesia and Tooth Extraction, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Tooth Extraction
- What is being tested?
- Midazolam Hydrochloride, Fentanyl and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2016to 10 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) health class I or II
- Existing clinical population
Who cannot join
- Do not meet the Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
NYCHHC - Jacobi Medical Center and North Central Bronx Hospital
The Bronx, New York, 10461
About this study
The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Measures of recovery, amnesia testing 20 minutes after induction and after completion of recovery tests, patient satisfaction, and surgeon satisfaction will be evaluated. The data from this pilot study will be used to obtain preliminary estimates of effect sizes and to select primary and secondary endpoints for the design of a larger scale and more definitive trial of the two anesthetic approaches.
Read the detailed description
The widespread application of various ambulatory anesthetic techniques has paralleled the rapid rise of ambulatory surgery. It has been estimated that over half of all elective surgery is performed in an ambulatory setting. In addition, well over 3,000,000 intravenous sedations are administered in dental offices annually where local anesthesia is obtainable to control intraoperative pain. These intravenous sedation techniques have historically been an integral part of pain and anxiety control in the dental setting and have now gained widespread application in all of ambulatory surgery. A number of intravenous anesthetic techniques have been developed to achieve sedation levels ranging from conscious sedation where patients respond purposefully to verbal commands to deep sedation where patients cannot be easily aroused and protective reflexes may be altered. The goal of all of these techniques is to create a comfortable environment for the patient and a cooperative patient for the surgeon. Ideal technique should pose minimal physiologic challenge to the patient while providing amnesia for the procedure. Most of the intravenous sedation techniques in widespread use include a combination of drugs. These combinations function in an additive if not synergistic way. The pharmacological properties of their constituents achieve this ideal. The most frequently used drug when used alone and the most common to the various combinations is midazolam, a benzodiazepine. Midazolam has been shown to provide safe sedation with reliable anterograde amnesia. The duration of these effects is dose dependent. A short acting narcotic, usually fentanyl, is often times included to increase sedation levels and to add a modicum of analgesia. Other short acting agents can also be included to deepen the sedation level. These agents are usually added in incremental doses as the surgical setting requires. Both propofol and ketamine can induce general anesthesia but in significantly smaller doses provide additional sedation. These two agents come from different drug classes. Proponents of each cite advantages and disadvantages. Nitrous oxide is also commonly used in the dental setting.
- Conditions
- Anesthesia, Tooth Extraction
- Keywords
- Ambulatory Oral Surgery, Maxillofacial Surgery, Intravenous, Ketamine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam HydrochlorideDrug
Also called Versed
Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor
FentanylDrug
Also called (N-phenyl-N-[1-(2-phenylethyl)-4piperidinyl]propanamide); Sublimaze, Actiq, Duragesic, Abstral, Subsys, and Ionsys
Synthetic opioid drug used as an analgesic.
KetamineDrug
Also called Ketalar
General Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist
Propofol injectionDrug
Also called 2,6-diisopropylphenol; Diprivan
General Anesthetic. GABA receptor modulator and calcium channel blocker
Nitrous oxideDrug
Also called Nitrous, laughing gas
Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Active comparator | 1. Midazolam 0.05 mg/kg - rounded to closest ½ mg
2. Fentanyl 50 micrograms (mcg) for patients less than or equal to 70kg and 75 mcg for those over 70 kg
3. Ketamine 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5mg Midazolam, 50 mcg Fentanyl, 20 mg Ketamine)
4. Additional intermittent dosage of Ketamine - 15 mg per surgeon's request
All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label. Receives: Drug: Midazolam Hydrochloride; Drug: Fentanyl; Drug: Ketamine; Drug: Nitrous oxide |
| Propofol Group | Active comparator | 1. Midazolam 0.05 mg/kg - rounded to closest ½ mg
2. Fentanyl 50 mcg for patients less than or equal to 70 kg and 75 mcg for those over 70 kg
3. Propofol 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5 mg Midazolam, 50 micrograms Fentanyl, 20 mg Propofol)
4. Additional intermittent dosage of Propofol - 15 mg per surgeon's request
All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label. Receives: Drug: Midazolam Hydrochloride; Drug: Fentanyl; Drug: Propofol injection; Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction was assessed using a patient evaluation survey administered following the procedure just prior to discharge. The survey consisted of 3 questions, 1 categorical and 2 ordinal. For purposes of this study, the 2 ordinal measures: "How do you feel now?" and "I would recommend this type of intravenous sedation to my family/friends" will be scored from 1-3 and 1-4, respectively for an overall possible scoring range of 2-7. Higher scores are associated with increased patient satisfaction. Satisfaction scores will be summarized by study arm.
Measured: Postoperatively, approximately 1 hour on day of procedure
Surgeon Satisfaction
Surgeon satisfaction will be assessed by a surgeon's satisfaction survey administered following the procedure. The survey consisted of 3 questions which asked the surgeon to assess their level of satisfaction with the sedation regimen during local anesthesia, during the surgery, and overall satisfaction. Each of the three were rated as 1 ("Poor"), 2 ("Adequate"), or 3 ("Excellent") for an overall possible scoring range of 3-9. Higher scores are associated with increased surgeon satisfaction. Surgeon satisfaction scores will be summarized by study arm.
Measured: Postoperatively, approximately 1 hour
Recovery - Paper Test
Recovery will be assessed using a simple repeated measure paper and pencil test (PS Form 9a). This test presented participants with 25 rows of numbers. Each row consisted of a circled number at the beginning of the string of numbers. Patients were asked to cross out each number in a row that is like the circled number. The number of successfully completed rows were tabulated for each patient and change from baseline was summarized by study arm.
Measured: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
Recovery - One Leg Standing Test
Recovery will also be assessed by way of a 30 second one leg standing test administered prior to and following induction of anesthesia. The percentage of participants who are able to stand for at least 30 seconds will be summarized by study arm.
Measured: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
Amnesia - Visual Stimuli
Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for visual stimuli will be assessed by having the patient verbally identify common objects (i.e., cup, pen, tape, and keys) presented during surgery. Patients will be asked to recall the items postoperatively. Recall of visual stimuli will be summarized by study arm using basic descriptive statistics.
Measured: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
Amnesia - Tactile Stimuli
Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for tactile stimuli will be assessed by touching the patient with a pin on one of their four limbs and asking for recall. Recall of tactile stimuli will be summarized by study arm using basic descriptive statistics.
Measured: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start4 Oct 2016
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen S Gelfman, MD, DDS, Principal investigator, New York City Health and Hospitals (NYCHHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867068
- Sponsor's protocol ID
- 2014-3556
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Association of Oral and Maxillofacial Surgeons Parameters of Care: Clinical Practice Guidelines. 2012.
Braidy HF, Singh P, Ziccardi VB. Safety of deep sedation in an urban oral and maxillofacial surgery training program. J Oral Maxillofac Surg. 2011 Aug;69(8):2112-9. doi: 10.1016/j.joms.2011.04.017.
PubMed 21783001Craig DC, Wildsmith JA; Royal College of Anaesthetists; Royal College of Surgeons of England. Conscious sedation for dentistry: an update. Br Dent J. 2007 Dec 8;203(11):629-31. doi: 10.1038/bdj.2007.1105.
PubMed 18065980Goktay O, Satilmis T, Garip H, Gonul O, Goker K. A comparison of the effects of midazolam/fentanyl and midazolam/tramadol for conscious intravenous sedation during third molar extraction. J Oral Maxillofac Surg. 2011 Jun;69(6):1594-9. doi: 10.1016/j.joms.2010.09.005. Epub 2011 Feb 1.
PubMed 21277062Peskin RM. Contemporary intravenous anesthetic agents and delivery systems: propofol. Anesth Prog. 1992;39(4-5):178-84. No abstract available.
PubMed 1344020Sims PG, Kates CH, Moyer DJ, Rollert MK, Todd DW. Anesthesia in outpatient facilities. J Oral Maxillofac Surg. 2012 Nov;70(11 Suppl 3):e31-49. doi: 10.1016/j.joms.2012.07.030. No abstract available.
PubMed 23128005Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
PubMed 15017641Personal Communication. Oral and Maxillofacial Surgery National Insurance Company. 2013.
Blankstein KC. Low-dose intravenous ketamine: an effective adjunct to conventional deep conscious sedation. J Oral Maxillofac Surg. 2006 Apr;64(4):691-2. doi: 10.1016/j.joms.2005.11.038. No abstract available.
PubMed 16546650Casagrande AM. Propofol for office oral and maxillofacial anesthesia: the case against low-dose ketamine. J Oral Maxillofac Surg. 2006 Apr;64(4):693-5. doi: 10.1016/j.joms.2005.11.039. No abstract available.
PubMed 16546651Cillo JE Jr. Analysis of propofol and low-dose ketamine admixtures for adult outpatient dentoalveolar surgery: a prospective, randomized, positive-controlled clinical trial. J Oral Maxillofac Surg. 2012 Mar;70(3):537-46. doi: 10.1016/j.joms.2011.08.036. Epub 2011 Dec 16.
PubMed 22177821Driscoll EJ, Gelfman SS, Sweet JB, Butler DP, Wirdzck PR, Medlin T. Thrombophlebitis after intravenous use of anesthesia and sedation: its incidence and natural history. J Oral Surg. 1979 Nov;37(11):809-15.
PubMed 290773Haas DA, Harper DG. Ketamine: a review of its pharmacologic properties and use in ambulatory anesthesia. Anesth Prog. 1992;39(3):61-8.
PubMed 1308374Idvall J, Ahlgren I, Aronsen KR, Stenberg P. Ketamine infusions: pharmacokinetics and clinical effects. Br J Anaesth. 1979 Dec;51(12):1167-73. doi: 10.1093/bja/51.12.1167.
PubMed 526385Kramer KJ, Ganzberg S, Prior S, Rashid RG. Comparison of propofol-remifentanil versus propofol-ketamine deep sedation for third molar surgery. Anesth Prog. 2012 Fall;59(3):107-17. doi: 10.2344/12-00001.1.
PubMed 23050750
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
- Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT06867068
- Acronym / sponsor ID
- 2014-3556
- Conditions
- Anesthesia, Tooth Extraction
- Keywords
- Ambulatory Oral Surgery, Maxillofacial Surgery, Intravenous, Ketamine, Propofol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 10 Mar 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.
The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Measures of recovery, amnesia testing 20 minutes after induction and after completion of recovery tests, patient satisfaction, and surgeon satisfaction will be evaluated. The data from this pilot study will be used to obtain preliminary estimates of effect sizes and to select primary and secondary endpoints for the design of a larger scale and more definitive trial of the two anesthetic approaches.
Detailed description
The widespread application of various ambulatory anesthetic techniques has paralleled the rapid rise of ambulatory surgery. It has been estimated that over half of all elective surgery is performed in an ambulatory setting. In addition, well over 3,000,000 intravenous sedations are administered in dental offices annually where local anesthesia is obtainable to control intraoperative pain. These intravenous sedation techniques have historically been an integral part of pain and anxiety control in the dental setting and have now gained widespread application in all of ambulatory surgery. A number of intravenous anesthetic techniques have been developed to achieve sedation levels ranging from conscious sedation where patients respond purposefully to verbal commands to deep sedation where patients cannot be easily aroused and protective reflexes may be altered. The goal of all of these techniques is to create a comfortable environment for the patient and a cooperative patient for the surgeon. Ideal technique should pose minimal physiologic challenge to the patient while providing amnesia for the procedure. Most of the intravenous sedation techniques in widespread use include a combination of drugs. These combinations function in an additive if not synergistic way. The pharmacological properties of their constituents achieve this ideal. The most frequently used drug when used alone and the most common to the various combinations is midazolam, a benzodiazepine. Midazolam has been shown to provide safe sedation with reliable anterograde amnesia. The duration of these effects is dose dependent. A short acting narcotic, usually fentanyl, is often times included to increase sedation levels and to add a modicum of analgesia. Other short acting agents can also be included to deepen the sedation level. These agents are usually added in incremental doses as the surgical setting requires. Both propofol and ketamine can induce general anesthesia but in significantly smaller doses provide additional sedation. These two agents come from different drug classes. Proponents of each cite advantages and disadvantages. Nitrous oxide is also commonly used in the dental setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Active comparator | Drug: Midazolam Hydrochloride, Drug: Fentanyl, Drug: Ketamine, Drug: Nitrous oxide1. Midazolam 0.05 mg/kg - rounded to closest ½ mg 2. Fentanyl 50 micrograms (mcg) for patients less than or equal to 70kg and 75 mcg for those over 70 kg 3. Ketamine 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5mg Midazolam, 50 mcg Fentanyl, 20 mg Ketamine) 4. Additional intermittent dosage of Ketamine - 15 mg per surgeon's request All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label. |
| Propofol Group | Active comparator | Drug: Midazolam Hydrochloride, Drug: Fentanyl, Drug: Propofol injection, Drug: Nitrous oxide1. Midazolam 0.05 mg/kg - rounded to closest ½ mg 2. Fentanyl 50 mcg for patients less than or equal to 70 kg and 75 mcg for those over 70 kg 3. Propofol 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5 mg Midazolam, 50 micrograms Fentanyl, 20 mg Propofol) 4. Additional intermittent dosage of Propofol - 15 mg per surgeon's request All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) health class I or II
- Existing clinical population
Key exclusion criteria (1 listed)
- Do not meet the Inclusion Criteria
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 |
|---|---|---|
| Midazolam HydrochlorideAlso: VersedShort-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor | Drug | Ketamine Group, Propofol Group |
| FentanylAlso: (N-phenyl-N-[1-(2-phenylethyl)-4piperidinyl]propanamide); Sublimaze, Actiq, Duragesic, Abstral, Subsys, and IonsysSynthetic opioid drug used as an analgesic. | Drug | Ketamine Group, Propofol Group |
| KetamineAlso: KetalarGeneral Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist | Drug | Ketamine Group |
| Propofol injectionAlso: 2,6-diisopropylphenol; DiprivanGeneral Anesthetic. GABA receptor modulator and calcium channel blocker | Drug | Propofol Group |
| Nitrous oxideAlso: Nitrous, laughing gasModulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents | Drug | Ketamine Group, Propofol Group |
Primary outcome
Patient Satisfaction
Time frame: Postoperatively, approximately 1 hour on day of procedure
Patient satisfaction was assessed using a patient evaluation survey administered following the procedure just prior to discharge. The survey consisted of 3 questions, 1 categorical and 2 ordinal. For purposes of this study, the 2 ordinal measures: "How do you feel now?" and "I would recommend this type of intravenous sedation to my family/friends" will be scored from 1-3 and 1-4, respectively for an overall possible scoring range of 2-7. Higher scores are associated with increased patient satisfaction. Satisfaction scores will be summarized by study arm.
Surgeon Satisfaction
Time frame: Postoperatively, approximately 1 hour
Surgeon satisfaction will be assessed by a surgeon's satisfaction survey administered following the procedure. The survey consisted of 3 questions which asked the surgeon to assess their level of satisfaction with the sedation regimen during local anesthesia, during the surgery, and overall satisfaction. Each of the three were rated as 1 ("Poor"), 2 ("Adequate"), or 3 ("Excellent") for an overall possible scoring range of 3-9. Higher scores are associated with increased surgeon satisfaction. Surgeon satisfaction scores will be summarized by study arm.
Recovery - Paper Test
Time frame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
Recovery will be assessed using a simple repeated measure paper and pencil test (PS Form 9a). This test presented participants with 25 rows of numbers. Each row consisted of a circled number at the beginning of the string of numbers. Patients were asked to cross out each number in a row that is like the circled number. The number of successfully completed rows were tabulated for each patient and change from baseline was summarized by study arm.
Recovery - One Leg Standing Test
Time frame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
Recovery will also be assessed by way of a 30 second one leg standing test administered prior to and following induction of anesthesia. The percentage of participants who are able to stand for at least 30 seconds will be summarized by study arm.
Amnesia - Visual Stimuli
Time frame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for visual stimuli will be assessed by having the patient verbally identify common objects (i.e., cup, pen, tape, and keys) presented during surgery. Patients will be asked to recall the items postoperatively. Recall of visual stimuli will be summarized by study arm using basic descriptive statistics.
Amnesia - Tactile Stimuli
Time frame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for tactile stimuli will be assessed by touching the patient with a pin on one of their four limbs and asking for recall. Recall of tactile stimuli will be summarized by study arm using basic descriptive statistics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BackgroundAmerican Association of Oral and Maxillofacial Surgeons Parameters of Care: Clinical Practice Guidelines. 2012.
- Background: PubMed 21783001Braidy HF, Singh P, Ziccardi VB. Safety of deep sedation in an urban oral and maxillofacial surgery training program. J Oral Maxillofac Surg. 2011 Aug;69(8):2112-9. doi: 10.1016/j.joms.2011.04.017.
- Background: PubMed 18065980Craig DC, Wildsmith JA; Royal College of Anaesthetists; Royal College of Surgeons of England. Conscious sedation for dentistry: an update. Br Dent J. 2007 Dec 8;203(11):629-31. doi: 10.1038/bdj.2007.1105.
- Background: PubMed 21277062Goktay O, Satilmis T, Garip H, Gonul O, Goker K. A comparison of the effects of midazolam/fentanyl and midazolam/tramadol for conscious intravenous sedation during third molar extraction. J Oral Maxillofac Surg. 2011 Jun;69(6):1594-9. doi: 10.1016/j.joms.2010.09.005. Epub 2011 Feb 1.
- Background: PubMed 1344020Peskin RM. Contemporary intravenous anesthetic agents and delivery systems: propofol. Anesth Prog. 1992;39(4-5):178-84. No abstract available.
- Background: PubMed 23128005Sims PG, Kates CH, Moyer DJ, Rollert MK, Todd DW. Anesthesia in outpatient facilities. J Oral Maxillofac Surg. 2012 Nov;70(11 Suppl 3):e31-49. doi: 10.1016/j.joms.2012.07.030. No abstract available.
- Background: PubMed 15017641Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
- BackgroundPersonal Communication. Oral and Maxillofacial Surgery National Insurance Company. 2013.
- Background: PubMed 16546650Blankstein KC. Low-dose intravenous ketamine: an effective adjunct to conventional deep conscious sedation. J Oral Maxillofac Surg. 2006 Apr;64(4):691-2. doi: 10.1016/j.joms.2005.11.038. No abstract available.
- Background: PubMed 16546651Casagrande AM. Propofol for office oral and maxillofacial anesthesia: the case against low-dose ketamine. J Oral Maxillofac Surg. 2006 Apr;64(4):693-5. doi: 10.1016/j.joms.2005.11.039. No abstract available.
- Background: PubMed 22177821Cillo JE Jr. Analysis of propofol and low-dose ketamine admixtures for adult outpatient dentoalveolar surgery: a prospective, randomized, positive-controlled clinical trial. J Oral Maxillofac Surg. 2012 Mar;70(3):537-46. doi: 10.1016/j.joms.2011.08.036. Epub 2011 Dec 16.
- Background: PubMed 290773Driscoll EJ, Gelfman SS, Sweet JB, Butler DP, Wirdzck PR, Medlin T. Thrombophlebitis after intravenous use of anesthesia and sedation: its incidence and natural history. J Oral Surg. 1979 Nov;37(11):809-15.
- Individual participant dataSharing planned: No
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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.
Stephen S Gelfman, MD, DDS principal investigator
New York City Health and Hospitals (NYCHHC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam Hydrochloride, Fentanyl and Ketamine in people with Anesthesia and Tooth Extraction, run by Albert Einstein College of Medicine at 1 site in United States.
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 2 inclusion and 1 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: finished, 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Satisfaction (time frame: Postoperatively, approximately 1 hour on day of procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867068, which also lists 25 linked publications.
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.