Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Success Rate of Pupal Anesthesia
研究概览
简要总结
The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
详细描述
In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. [9] Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. Even though success rates between 83 and 90 % have been reported for adults and children >40kg, [10] FDA label (Section 14.2) provides data for children (>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. [9]
- One 0.1 mL spray for patients weighing 10 kg to less than 20 kg;
- Two 0.1 mL sprays for 20 kg to less than 40 kg; or
- Two 0.2 mL sprays for patients weighing 40 kg or more.
With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:
- Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg)
- Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Class I or II
- •Preoperative heart rate of 55 to 100 beats per minute
- •Maximum blood pressure reading of 166/100 mmHg
- •Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
- •Additional Pediatric Inclusion Criteria:
- •Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
- •Additional Endodontic Inclusion Criteria:
- •Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
- •Additional General Practice Inclusion Criteria:
- •Adults who require restorations in the maxillary teeth that would need local anesthesia
排除标准
- •Inadequately controlled thyroid disease
- •Five or more nosebleeds in the past month
- •Known allergy to any study drug or para-aminobenzoic acid
- •History of methemoglobinemia
- •Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
- •Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
研究组 & 干预措施
Kovanaze Nasal Spray (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
干预措施: Kovanaze Nasal Spray (Drug)
Articaine Injections (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
干预措施: Articaine Injection (Drug)
结局指标
主要结局
Success Rate of Pupal Anesthesia
时间窗: immediately after dental procedure, an average of 3 hours
% dental procedures completed without the need for rescue anesthesia
次要结局
- Spread of Anesthesia(immediately after dental procedure, an average of 3 hours)
- Anxiety(immediately after dental procedure, an average of 3 hours)
- Change in Blood Pressure(from baseline to immediately after dental procedure)
- Change in Anxiety Level(from baseline to immediately after dental procedure)
- Change in Heart Rate(from baseline to immediately after dental procedure)
- Change in Pain(from baseline to immediately after dental procedure)