Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction With Midazolam, Diazepam and Nitrous Oxide - Randomized Clinical Trial.

The surgery for the extraction of the third molars is a procedure in Dentistry that generates a large picture of anxiety in the patient. One of the ways to try to soften this picture, are the professionals to use sedation. Thus, the objective of this study was to evaluate three sedation protocols, and to compare them with vital signs values, in order to obtain the sedation method with greater patients stability.

Study Overview

• Status: Completed
• Conditions: Anxiety Disease
• Intervention / Treatment: Drug: Midazolam; Drug: Nitrous Oxide + Oxygen Gas; Procedure: Third molar extraction; Drug: Diazepam

Detailed Description

The surgery for the extraction of third molars is one of the procedures in Dentistry that generates a great picture of anxiety in the patients, due to the expectation of pain and discomfort in the postoperative period, but mainly in the trans-operative period. One of the ways to try to minimize this situation is to use sedation, which is a relatively safe procedure performed by trained professionals and with an accurate indication for anxious patients. There are several protocols in the literature, but few comparative studies. Thus, the objective of this study was to evaluate three sedation protocols. For this purpose, 120 patients who required surgical treatment for extraction of third molars, aged between 18 and 30 years, and whose anxiety was moderate to severe according to the Corah Anxiety Scale from the School of Dentistry of São José Dos Campos (UNESP). These patients were randomly divided into three Groups: Group I - oral sedation with diazempam 5 mg; Group II - oral sedation with midazolam 7.5 mg and Group III - inhalation sedation with 40% of nitrous oxide . Prior to sedation, anxiety was quantified through the Corah Anxiety Scale. Vital signs (blood pressure, heart rate and oxygen saturation) were measured before sedation, after sedation, in the trans-operative period and 15 minutes after the end of sedation. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy patients (ASA1), without surgical contra indications, requiring avulsion of the included third and / or semi-molar third molars,
• Between the ages of 18 and 30,
• Patients who agreed to voluntarily participate in the research, after knowing the risks and benefits, and signing the Informed Consent Form (TCLE).
• Patients who presented moderate to high anxiety level in the questionnaire proposed by Corah in 1969.

Exclusion Criteria:

• Patients with any systemic or local change that contra indicated the procedure,
• Use of anti-inflammatories in the last 15 days,
• Pericoronitis,
• Patients who did not accept the Informed Consent Form (TCLE)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diazepam; Sedation of the anxious patient with diazepam 5 mg for measuring vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.	Drug: Midazolam; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with midazolam 7.5mg during the extraction procedure and 15 minutes after the extraction. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Other Names: Dormonid; Midazolam Oral Tablet; Drug: Nitrous Oxide + Oxygen Gas; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of sedation Inhalation with the mixture of 40% of nitrou oxide and 60% of oxygen, during the exodontia procedure and 15 minutes later. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the discharge criteria performed, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid, and after the accomplishment of the test developed by Trieger et al.,(1971).; Other Names: Nitrous Oxide; Nitrous Oxide Inhalant Product; Procedure: Third molar extraction; Anxious patients in need of third molar extraction; Other Names: Third molar surgery
ACTIVE_COMPARATOR: Midazolam; Sedation of the anxious patient with midazolam 7.5 mg for measurement of vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.	Drug: Nitrous Oxide + Oxygen Gas; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of sedation Inhalation with the mixture of 40% of nitrou oxide and 60% of oxygen, during the exodontia procedure and 15 minutes later. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the discharge criteria performed, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid, and after the accomplishment of the test developed by Trieger et al.,(1971).; Other Names: Nitrous Oxide; Nitrous Oxide Inhalant Product; Procedure: Third molar extraction; Anxious patients in need of third molar extraction; Other Names: Third molar surgery; Drug: Diazepam; Patients' vital signs (blood pressure, heart rate and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with diazepam 5mg, during the extraction procedure and 15 minutes after the extraction. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Other Names: Valium; Diazepam 5mg
ACTIVE_COMPARATOR: Nitrous Oxide + Oxygen Gas; Inhaled sedation of the mixture of 40% of nitrous oxide and 60% of oxygen gas for measurement of vital signs (blood pressure, heart rate, oxygen saturation) in the pre, trans and postoperative periods of third molar extraction.	Drug: Midazolam; Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with midazolam 7.5mg during the extraction procedure and 15 minutes after the extraction. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Other Names: Dormonid; Midazolam Oral Tablet; Procedure: Third molar extraction; Anxious patients in need of third molar extraction; Other Names: Third molar surgery; Drug: Diazepam; Patients' vital signs (blood pressure, heart rate and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with diazepam 5mg, during the extraction procedure and 15 minutes after the extraction. After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid.; Other Names: Valium; Diazepam 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of blood pressure change	Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with auscultatory instrument.	Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of heart rate change	Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.The investigator evaluated with oscillometric monitor.	Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery
Assessment of oxygen saturation change	Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide. The investigator evaluated with pulse oximeter	Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- During the exodontia - 15 minutes after the end of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrograde amnesia	Evaluated in anxious patients submitted to the exodontia of third molars, sedated with diazepam, midazolam and nitrous oxide.Retrograde amnesia was evaluated by the investigator through the adapted test of Bulach et al., (2005), where 6 images were shown to the patient for a period of 5 seconds each	Immediately the arrival of the patient and before receiving sedation - 30 minutes after the patient receives oral sedation or 5 minutes after inhaled sedation- 15 minutes after the end of surgery
Test of Trieger	Evaluated in anxious patients submitted to the exodontia of third molars, sedated with nitrous oxide. Only for the patients in the group undergoing nitrous oxide sedation, the test developed by Trieger et al., (1971) was performed according to Malamed (2012). The researcher provides a drawing to the patient for the union of the points closest to the ideal.	Measured 15 minutes after the end of surgery.]

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

General Publications

• Joshi S, Ansari AS, Mazumdar S, Ansari S. A comparative study to assess the effect of oral alprazolam as premedication on vital parameters of patients during surgical removal of impacted mandibular third molars. Contemp Clin Dent. 2016 Oct-Dec;7(4):464-468. doi: 10.4103/0976-237X.194125.
• Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
• Khader R, Oreadi D, Finkelman M, Jarmoc M, Chaudhary S, Schumann R, Rosenberg M. A prospective randomized controlled trial of two different sedation sequences for third molar removal in adults. J Oral Maxillofac Surg. 2015 Feb;73(2):224-31. doi: 10.1016/j.joms.2014.08.033. Epub 2014 Sep 16.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2015
• Primary Completion (ACTUAL): December 20, 2016
• Study Completion (ACTUAL): May 4, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (ACTUAL): May 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Benzodiazepines; Sedation; Nitrous Oxide; Exodontia
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Anesthetics, Inhalation; Neuromuscular Agents; Muscle Relaxants, Central; Midazolam; Nitrous Oxide; Diazepam
• Other Study ID Numbers: Universidade Estadual Paulista

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No