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STANDARDIZED PROTOCOL STANDARDIZED PROTOCOL FOR THE USE OF FOR THE USE OF
ORAL MIDAZOLAMORAL MIDAZOLAM
Dr. Samuel Benarroch MD, DDS, MSDr. Samuel Benarroch MD, DDS, MS
Assistant ProfessorAssistant Professor
Oral & Maxillofacial Surgery Residency ProgramOral & Maxillofacial Surgery Residency ProgramWoodhull Medical Center. New YorkWoodhull Medical Center. New York
Hospital Magallanes de Catia. CaracasHospital Magallanes de Catia. Caracas
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ANXIOLYSISANXIOLYSIS & SEDATION & SEDATION
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PURPOSEPURPOSE
Assess the safety and effectiveness Assess the safety and effectiveness of an oral anxiolysis sedation of an oral anxiolysis sedation
protocol for adults by means of a protocol for adults by means of a standardized midazolam dose forstandardized midazolam dose fordental treatments and ambulatory dental treatments and ambulatory
maxillofacial surgerymaxillofacial surgery
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DESIGNDESIGN
• Multiple centersMultiple centers
• Retrospective study Retrospective study
• Conducted from 1998 to 2004Conducted from 1998 to 2004
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTION SEXSEX
SEX NUMBER %
MALE 83 24.20
FEMALE 260 75.80
TOTAL 343 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTION
AGEAGEAGE NUMBER %
15 – 20 138 40.23
21 – 30 163 47.29
31 – 40 28 8.05
41 – 50 8 2.47
> 50 6 2.05
TOTAL 343 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTION
WEIGHTWEIGHT WEIGHT NUMBER %
55 – 5943 12.5
60 – 64 128 37.3
65 – 6994 27.4
70 – 74 49 14.3
> 75 29 8.5
TOTAL 343 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTION Physical Status Classification
ASA NUMBER %
ASA I 29575.80
ASA II 48 24.20
TOTAL 343 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTION SURGICAL PROCEDURES
PROCEDURE NUMBER %
ORAL SURGERY 329 95.92
COSMETIC SURGERY
14 4.08
TOTAL 343 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONORAL SURGERYORAL SURGERY
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONORAL SURGERYORAL SURGERY
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONORAL SURGERYORAL SURGERY
PROCEDURES NUMBER %
THIRD MOLAR EXTRACTION 4 180 54.7MULTIPLES DENTAL
EXTRACTIONS 45 13.7
MULTIPLE IMPLANTS SURGERY 67 20.4
PREPROSTHETIC SURGERY 24 7.2
OTHER 13 4
TOTAL 329 100
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONCOSMETIC SURGERYCOSMETIC SURGERY
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONCOSMETIC SURGERYCOSMETIC SURGERY
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONCOSMETIC SURGERYCOSMETIC SURGERY
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PATIENT DISTRIBUTIONPATIENT DISTRIBUTIONCOSMETIC SURGERYCOSMETIC SURGERY
PROCEDURES NUMBER %
GENIOPLASTY 7 50.3
RHINOPLASTY 3 21.3
BLEPHAROPLASTY 2 14.2
FACIAL LIPOSUCTION 1 7.1
Mini lifting 1 7.1
TOTAL 14 100
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PROTOCOLSPROTOCOLS• Oral anxiolysis sedation indications• Patient assessment
– ASA I or II– Weight up 55 Kgs
Minimal Monitoring equipments
• Medications• Anxiolysis sedation management
– monitoring and documentation of the procedure– discharge criteria– Post sedation instructions
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ORAL ANXIOLYSIS SEDATION ORAL ANXIOLYSIS SEDATION INDICATIONINDICATION
• Fear, Stress and AnxietyFear, Stress and Anxiety about having about having a dental treatment or oral and a dental treatment or oral and maxillofacial surgerymaxillofacial surgery
• History of bad dental or surgical History of bad dental or surgical experiencesexperiences
• Low Pain thresholdLow Pain threshold
• Long dental or surgical appointmentsLong dental or surgical appointments
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PATIENT EVALUATIONPATIENT EVALUATION
1. Physical status assessment (review of systems, vital signs, airway, cardiopulmonary reserve).
2. Past and present drug history including drug allergies.3. Previous adverse experience with sedation and
analgesia as well as with regional and general anesthesia.
4. Results of relevant diagnostic studies.5. History of tobacco, alcohol, and substance use/abuse.6. Verification of patient NPO status.7. Plan and choice of sedation.8. Transportation arrangements for patients who are
expected to be discharged from the facility.
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MONITORING EQUIPMENTSMONITORING EQUIPMENTS
1. A self-inflating positive-pressure oxygen delivery system capable of administering oxygen
2. Appropriate sizes of airway management equipment (e.g., masks, oral airways, endotracheal tubes, and laryngoscopes).
3. A suction apparatus with catheters and Yankauer-type rigid suction device.
4. Monitors including those capable of measuring:A. Oxygenation (pulse oximeter)A. Oxygenation (pulse oximeter)B. Blood Pressure (automated or manual device)B. Blood Pressure (automated or manual device)C. Heart RateC. Heart Rate
5. Telephone or other device capable of summoning assistance in an emerge
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MONITORING OF THE MONITORING OF THE PROCEDUREPROCEDURE
• Baseline vital signs shall be recorded in the sedation record before administering sedation and analgesia.
• During sedationDuring sedation, the following vital signs shall be , the following vital signs shall be
monitored and documented in the sedation record monitored and documented in the sedation record with with 5 minute intervals5 minute intervals::– Heart rate - continuous monitoringHeart rate - continuous monitoring. This must be done by
ECG in all patients with cardiac or pulmonary disease, and may be monitored by pulse oximetry in all other patients.
– Respiratory rate– Oxygen saturation (pulse oximeter) - continuous monitoringOxygen saturation (pulse oximeter) - continuous monitoring– Blood Pressure
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DISCHARGE CRITERIAPROTOCOL
• Patient is easily awakened by normal or softly spoken verbal commands.
• Patient is oriented when awake as appropriate for age.
• All vital signs are stable• There is no significant risk of losing protective
reflexes.• Patient is able to maintain pre-procedure
mobility with minimal assistance as appropriate for the procedure.
• Minimal nausea and/or dizziness
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POST SEDATION POST SEDATION INSTRUCTIONSINSTRUCTIONS
1. Information about expected behavior following sedation.
2. Instructions for eating.3. Warning signs of complications.4. Special instructions in case of emergency.5. A telephone number to contact the medical
service responsible for the patient’s care that is available 24 hours per day.
6. A notation shall be placed in the medical record that instructions were received and understood by a responsible person or adult patient
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MEDICATIONSMEDICATIONS
MIDAZOLAMMIDAZOLAM
• Initial dose 7.5 mg, 90 minutes prior to the surgery
• Subsequent dose 0.20 mg/kg, 30 minutes prior to start the anesthesia infiltration
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LEVELS OF ANXIETYLEVELS OF ANXIETY
• Pre-operative Pre-operative
• Post operativePost operative– Immediate Immediate – Discharge from clinic Discharge from clinic
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ANXIETY MESUREMENTSANXIETY MESUREMENTS
• HEART RATEHEART RATE
• DIAPHORESISDIAPHORESIS
• ANXIETY SCALESANXIETY SCALES
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ANXIETY SCALEANXIETY SCALE
• No anxietyNo anxiety 11• Mild anxiety but tolerable Mild anxiety but tolerable 22• Moderate anxiety but tolerated Moderate anxiety but tolerated 33• Moderate anxiety not controlled by Moderate anxiety not controlled by
prescribed drugprescribed drug 44• Severe anxiety not controlled by Severe anxiety not controlled by
prescribed drugprescribed drug 55
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RESULTSRESULTS
• 54.7 % molar extraction and 13.7 multiples extraction• The length of surgical time ranged from 13-65 minutes (mean
time of surgery at 39.4 minutes). • 312 cases (91%) surgery lasting less than 50 minutes• No extra midazolam doses were necessary in any patient• The mean heart rate and respiratory rate were within
acceptable clinical limits. The lowest mean arterial oxygen saturation levels were 95 %, 75% had partial amnesia.
• Midazolam (second phase) sedation lasted about 55-65 minutes, producing good operating conditions and stable vital signs with adequate verbal response.
• The main adverse effects were drowsiness and dizziness on the same day
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PRE SURGERY PRE SURGERY ANXIETY CONTROLANXIETY CONTROL
30 minutes prior to surgery30 minutes prior to surgery• No anxiety 64.6 %• Mild anxiety but tolerable 22.5 % • Moderate anxiety but tolerated 10.3 %• Moderate anxiety not controlled by prescribed drug 1.6 %• Severe anxiety not controlled by prescribed drug 1.0 %
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POST SURGERY IMMEDIATE POST SURGERY IMMEDIATE ANXIETY CONTROLANXIETY CONTROL
10 minutes after surgery10 minutes after surgery No anxiety 56.4 % Mild anxiety but tolerable 18.5 % Moderate anxiety but tolerated 16.9 % Moderate anxiety not controlled by prescribed drug 5.1 % Severe anxiety not controlled by prescribed drug 3.1%
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ANXIETY CONTROLANXIETY CONTROL POST SURGERY POST SURGERY
1 HOUR 1 HOUR
• No anxiety 44.7 %• Mild anxiety but tolerable 20.6 % • Moderate anxiety but tolerated 31.7 %• Moderate anxiety not controlled by prescribed
drug 1.6 %• Severe anxiety not controlled by prescribed
drug 1.4 %
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ConclusionsConclusions
• The protocol proposed is a simple, safe, effective, and practical approach in the preoperative anxiety management in ambulatory patients
• Adequate patient comfort and cooperation is accomplished with minimal invasiveness and no adverse effects
• The Oral midazolam protocol may provide an alternative to other procedures
• Cost effective • Easy to use by medium trained personnel
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THANK YOUTHANK YOU
STANDARDIZED PROTOCOL FOR STANDARDIZED PROTOCOL FOR
THE USE OF ORAL MIDAZOLAMTHE USE OF ORAL MIDAZOLAM
Dr. Samuel Benarroch MD, DDS, MSDr. Samuel Benarroch MD, DDS, MS
Assistant ProfessorAssistant Professor
Oral & Maxillofacial Surgery Residency ProgramOral & Maxillofacial Surgery Residency ProgramWoodhull Medical Center. New YorkWoodhull Medical Center. New York
Hospital Magallanes de Catia. CaracasHospital Magallanes de Catia. Caracas
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