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Safety and Efficacy of Intranasal Dexmedetomidine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985697
Recruitment Status : Unknown
Verified December 2016 by Bon Secours Pediatric Dental Associates.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Bon Secours Pediatric Dental Associates

Brief Summary:
The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine when used in combination with oral midazolam and/or nitrous oxide for moderate sedation during pediatric outpatient dental procedures.

Condition or disease Intervention/treatment Phase
Safety and Efficacy of Intranasal Dexmedetomidine Drug: Dexmedetomidine Drug: Midazolam Hydrochloride Drug: Nitrous Oxide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intranasal Dexmedetomidine as a Sedative in Pediatric Dentistry: a Randomized, Double-blind Clinical Study
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IN DEX
Group IN DEX will receive a placebo dose of flavored water followed by 3 mcg/kg intranasal dexmedetomidine in conjunction with 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or placebo will not be given.
Drug: Dexmedetomidine
The intervention being tested is intranasal dexmedetomidine
Other Names:
  • Precedex
  • Dexdor
  • Dexdomitor
  • Sileo

Drug: Nitrous Oxide
Nitrous oxide to be administered in conjunction with other interventions, per study design.

Experimental: MIDDEX
Group MIDDEX will receive 3 mcg/kg intranasal dexmedetomidine and 0.5 mg/kg oral midazolam and 100% oxygen at a calculated flow rate (oxygen administration to function as placebo for nitrous oxide). If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
Drug: Dexmedetomidine
The intervention being tested is intranasal dexmedetomidine
Other Names:
  • Precedex
  • Dexdor
  • Dexdomitor
  • Sileo

Drug: Midazolam Hydrochloride
Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.
Other Name: Versed

Experimental: NOMIDDEX
Group NOMIDDEX will receive 3 mcg/kg intranasal dexmedetomidine, 0.5 mg/kg oral midazolam, and 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
Drug: Dexmedetomidine
The intervention being tested is intranasal dexmedetomidine
Other Names:
  • Precedex
  • Dexdor
  • Dexdomitor
  • Sileo

Drug: Midazolam Hydrochloride
Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.
Other Name: Versed

Drug: Nitrous Oxide
Nitrous oxide to be administered in conjunction with other interventions, per study design.

Active Comparator: CTRL
The control group, Group CTRL, will receive a placebo dose of normal saline and 0.5 mg/kg oral midazolam and 50/50 nitrous oxide/oxygen at a calculated flow rate. Midazolam was chosen as the control due to its well documented history of use in pediatric procedural sedations. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
Drug: Midazolam Hydrochloride
Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.
Other Name: Versed

Drug: Nitrous Oxide
Nitrous oxide to be administered in conjunction with other interventions, per study design.




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]
    Apnea, desaturation, airway obstruction, bradycardia, hypotension, fever, and inability to complete the procedure will be considered minor adverse events. Major adverse events are defined as death, aspiration, cardiac arrest, unplanned hospital admission, and level-of-care increase. Required interventions to correct adverse events will also be recorded (such as IV fluids to improve hypotension).

  2. Quality of Sedation [ Time Frame: 1 year ]
    Sedation quality and patient behavior will be evaluated using the criteria from the University of Michigan sedation scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients aged from 3 through 6 years of age.
  2. Patients who are appropriate for in-office sedation for dental care.

Exclusion Criteria:

  1. Patients younger than 3 or older than 6 years of age.
  2. History of failed sedation.
  3. BMI greater than 30.
  4. Patients weighing less than 10 kgs.
  5. Patients weighing more than 25 kgs.
  6. Patients who are deemed unsuitable for sedation by a physician at their preoperative history and physical.
  7. Patients who are deemed unsuitable for in-office sedation in accordance with Bon Secours policy (American Society of Anesthesiologists [ASA] Classification greater than II, Mallampati score greater than 2, Brodsky tonsil score greater than 2).
  8. Patients with sleep apnea.
  9. Patients with a history of an unfavorable reaction to DEX or clonidine.
  10. Patients with pulmonary hypertension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985697


Locations
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United States, Virginia
Bon Secours Pediatric Dental Associates
Richmond, Virginia, United States, 23230
Contact: John H Unkel, MD, DDS    804-893-8715    john_unkel@bshsi.org   
Contact: Carson M Cruise, DMD    804-893-8715    carson_cruise@bshsi.org   
Sub-Investigator: Carson M Cruise, DMD         
Sub-Investigator: Brittany L Ko, DDS         
Sponsors and Collaborators
Bon Secours Pediatric Dental Associates
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: DEXProtocol
Protocol for the study; includes introduction, design, and references/citations.

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Responsible Party: Bon Secours Pediatric Dental Associates
ClinicalTrials.gov Identifier: NCT02985697    
Other Study ID Numbers: 8001
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Nitrous Oxide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Anesthetics, Inhalation