Safety and Efficacy of Intranasal Dexmedetomidine as a Sedative in Pediatric Dentistry: a Randomized, Double-blind Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
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.
详细描述
The study will be organized as a prospective, randomized, double-blind trial in which children who meet the study criteria are randomly separated into three test groups (IN DEX, MIDDEX, and NOMIDDEX) and one control group (CTRL). Patients will be scheduled to complete one quadrant of dental care per sedation. Dental procedures to be performed include composite restorations, sealants, stainless steel crowns, pulp therapy, and extractions, with the exact number and type dependant on each patient's individual treatment plan.
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.
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.
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 3 through 6 years of age.
- •Patients who are appropriate for in-office sedation for dental care.
排除标准
- •Patients younger than 3 or older than 6 years of age.
- •History of failed sedation.
- •BMI greater than
- •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.
研究组 & 干预措施
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Nitrous Oxide (Drug)
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Midazolam Hydrochloride (Drug)
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Midazolam Hydrochloride (Drug)
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.
干预措施: Nitrous Oxide (Drug)
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.
干预措施: Midazolam Hydrochloride (Drug)
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.
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Adverse Events
时间窗: 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).
Quality of Sedation
时间窗: 1 year
Sedation quality and patient behavior will be evaluated using the criteria from the University of Michigan sedation scale.
次要结局
未报告次要终点