Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial

NCT05500261 | Unknown

• 1 other identifier: SYSKY-2022-119-03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and intensive care medicine departments, routinely intravenously. In recent years, intranasal administration of dexmedetomidine has also been reported for pediatric dentistry and adult alveolar surgery, showing good sedative and analgesic effects. However, these studies have problems such as single surgical types, small sample size, and few indicators analyzed. Therefore, the evaluation of intranasal administration of dexmedetomidine is still not comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety has not been reported yet. This project plans to carry out a randomized, double-blinded, placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and secondly verify it with placebo as the control. We plan to measure the object indicators, including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and to assess the subjective indicators using scales and questionnaires, thus comprehensively evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism additionally. We intend to help severe dental anxious patients completing dental treatments.

Conditions

Dental Anxiety

Keywords

Dexmedetomidine; Intranasal; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change of MDAS score

  Dental anxious score will be accessed by modified dental anxiety scale (MDAS), and the change of MDAS score will be calculated as the scores right after dental treatments minus the initial score before intervention.

  Change from baseline MDAS score right after finishing dental treatments, an average of 30 minutes

Secondary Outcomes (7)

• Change of plasma cortisol concentration

  Change from baseline plasma cortisol concentration right after finishing dental treatments, an average of 30 minutes

• Change of NTI score

  Change from baseline NTI score right after finishing dental treatments, an average of 30 minutes

• Change of OAA/S score

  Change from baseline OAA/S score right after finishing dental treatments, an average of 30 minutes

• Change of blood pressure (BP)

  Change from baseline BP right after finishing dental treatments, an average of 30 minutes.

• Change of heart rate (HR)

  Change from baseline HR right after finishing dental treatments, an average of 30 minutes.

Study Arms (3)

0.8 μg/kg intranasal dexmedetomidine

EXPERIMENTAL

Intranasal administration of 0.8 μg/kg dexmedetomidine

Drug: Dexmedetomidine

1.5 μg/kg intranasal dexmedetomidine

EXPERIMENTAL

Intranasal administration of 1.5 μg/kg dexmedetomidine

Drug: Dexmedetomidine

2.0 μg/kg intranasal dexmedetomidine

EXPERIMENTAL

Intranasal administration of 2.0 μg/kg dexmedetomidine

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

intranasal administration of dexmedetomidine

Also known as: intranasal, randomized controlled trial, dental anxiety

0.8 μg/kg intranasal dexmedetomidine; 1.5 μg/kg intranasal dexmedetomidine; 2.0 μg/kg intranasal dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign an informed consent form;
• Age 18 to 65 years old, regardless of gender;
• Diagnosed by a dentist and needs dental treatment;
• Can be immediately arranged for dental treatment after being evaluated by the clinician as having no contraindications;
• Graded as severe dental anxious (obtained using the MDAS modified dental anxiety scale);
• After controlling the symptoms of infection if with symptoms of acute/systemic infection, and can be arranged immediately after meeting the indications for dental treatments;
• BMI is 18.5 kg/m2\~25 kg/m2;
• After resting for 30 min, the SBP \< 180 mmHg, the DBP \< 110 mmHg, and the 60≤HR ≤ 120 bpm;
• For women who have not been menopausal or who have been under 1 year of menopause, a pregnancy test (blood or urine pregnancy test) should be performed during the screening period, and then the study and administration should be carried out after the pregnancy test is negative during the screening period.

You may not qualify if:

• Subjects who are not considered by the researcher to be suitable for nasal drops (such as severe rhinitis, nasal malformations, etc.);
• Subjects with a history of severe arrhythmias such as type II or above AV block or a history of cardiac insufficiency;
• Subjects with a history of myocardial infarction or unstable angina in the 6 months before the screening period;
• Subjects with a history of ischemic stroke or transient ischemic attack (TIA);
• Subjects with poor blood pressure control after drug therapy (hypertension: SBP≥180 mmHg, and/or DBP≥110 mmHg, or hypotension: SBP \<90 mmHg and/or DBP≤50 mmHg);
• Subjects with psychiatric disorders (such as schizophrenia, anxiety, depression, etc.) and cognitive dysfunction, or have a history of epilepsy, or previous abuse of psychotropic drugs and narcotic drugs;
• Subjects with a history of difficult airway disease or possibility, such as obstructive sleep apnea syndrome;
• Randomly, within 1 year of random, a history of drug abuse, a history of drug abuse and a history of alcohol abuse, i.e., a subject who drank more than 2 units of alcohol per day on average (1 unit = 360 ml of beer or 45 ml of liquor or 150 ml of wine with an alcohol content of 40%);
• Subjects who received selective alpha2-adrenoceptor agonists or antagonists within 14 days of randomization;
• Those who are allergic to dexmedetomidine hydrochloride or items used in stomatology;
• Pregnant or nursing women;
• Those who have a birth plan within 30 days before the screening period and half a year after the end of the trial, and are unwilling or unable to take effective contraception measures;
• Other circumstances in which the investigator determines that the subject is not suitable to participate in this study.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Related Publications (8)

• Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.

  PMID: 31206433 BACKGROUND

• Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT, Jusko WJ. Mechanism-based population pharmacokinetic and pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin Pharmacol. 2015 Oct;71(10):1197-207. doi: 10.1007/s00228-015-1913-0. Epub 2015 Aug 2.

  PMID: 26233335 BACKGROUND

• Coursin DB, Coursin DB, Maccioli GA. Dexmedetomidine. Curr Opin Crit Care. 2001 Aug;7(4):221-6. doi: 10.1097/00075198-200108000-00002.

  PMID: 11571417 BACKGROUND

• Shetty SK, Aggarwal G. Efficacy of Intranasal Dexmedetomidine for Conscious Sedation in Patients Undergoing Surgical Removal of Impacted Third Molar: A Double-Blind Split Mouth Study. J Maxillofac Oral Surg. 2016 Dec;15(4):512-516. doi: 10.1007/s12663-016-0889-3. Epub 2016 Apr 21.

  PMID: 27833345 RESULT

• Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.

  PMID: 23497981 RESULT

• Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.

  PMID: 21685111 RESULT

• Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019.

  PMID: 31114165 RESULT

• Ryu DS, Lee DW, Choi SC, Oh IH. Sedation Protocol Using Dexmedetomidine for Third Molar Extraction. J Oral Maxillofac Surg. 2016 May;74(5):926.e1-7. doi: 10.1016/j.joms.2015.12.021. Epub 2016 Jan 7.

  PMID: 26850877 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Randomized Controlled Trials as Topic

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Controlled Clinical Trials as Topic; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zeman Qin, Master

  Department of General Dentistry, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeman Qin, Master

CONTACT

15018419746; qinzm@mail.sysu.edu.cn

Liushan Ou, Master

CONTACT

020-81332587; sysyxllwyh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 15, 2022
• Study Start: November 1, 2022
• Primary Completion: July 23, 2023
• Study Completion: July 23, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after the publication of the paper about this trial
• Access Criteria: IPD will be accessed by the Data and Safety Monitoring Committee and all researchers in related fields