Safety and Efficacy of Intranasal Dexmedetomidine

NCT02985697 | Unknown Phase 4 DMC

• 1 other identifier: 8001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Efficacy of Intranasal Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  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).

  1 year

• Quality of Sedation

  Sedation quality and patient behavior will be evaluated using the criteria from the University of Michigan sedation scale.

  1 year

Study Arms (4)

IN DEX

EXPERIMENTAL

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; Drug: Nitrous Oxide

MIDDEX

EXPERIMENTAL

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; Drug: Midazolam Hydrochloride

NOMIDDEX

EXPERIMENTAL

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; Drug: Midazolam Hydrochloride; Drug: Nitrous Oxide

CTRL

ACTIVE COMPARATOR

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; Drug: Nitrous Oxide

Interventions

Dexmedetomidine DRUG

The intervention being tested is intranasal dexmedetomidine

Also known as: Precedex, Dexdor, Dexdomitor, Sileo

IN DEX; MIDDEX; NOMIDDEX

Midazolam Hydrochloride DRUG

Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.

Also known as: Versed

CTRL; MIDDEX; NOMIDDEX

Nitrous Oxide DRUG

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

CTRL; IN DEX; NOMIDDEX

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients younger than 3 or older than 6 years of age.
• History of failed sedation.
• BMI greater than 30.
• Patients weighing less than 10 kgs.
• Patients weighing more than 25 kgs.
• Patients who are deemed unsuitable for sedation by a physician at their preoperative history and physical.
• 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).
• Patients with sleep apnea.
• Patients with a history of an unfavorable reaction to DEX or clonidine.
• Patients with pulmonary hypertension.

Sponsors & Collaborators

• Bon Secours Pediatric Dental Associates: lead

Study Sites (1)

Bon Secours Pediatric Dental Associates

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)