Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Proportion of patients that are successfully anesthetized for endodontic treatment
研究概览
简要总结
Purpose:
To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze tetracaine/oxymetazoline nasal spray for root canal treatment of vital premolar and anterior teeth needing root canal treatment.
Participants:
30 adult patients with a vital upper anterior or premolar tooth (#4-13) with a diagnosis indicating need root canal treatment and who are seeking treatment in the UNC Chapel Hill School of Dentistry.
Procedures (methods):
Qualifying patients will be anesthetized with tetracaine/oxymetazoline nasal spray anesthetic in order to facilitate completion of their clinically required, standard of care root canal treatment. Research procedures include blood pressure monitoring and pain assessment using a visual analogue pain scale.
详细描述
The study will be undertaken in the UNC Chapel Hill School of Dentistry student clinics. Eligible patients seeking treatment at the School of Dentistry will be recruited to the study and written informed consent obtained.
Operator Training:
Operators will obtain online and in person training to ensure consistent, accurate use of the nasal spray. Anesthesia of all study subjects will be performed by UNC Chapel Hill Graduate Endodontics residents.
Patient Selection:
A total of thirty adult subjects (>18years old) seeking endodontic treatment will be recruited to the study. Inclusion criteria are: American Society of Anesthesiologists class I or II; Preoperative heart rate of 55 to 100 beats per minute; a maximum blood pressure reading of 166/100 mmHg; maxillary anterior tooth or premolar with a diagnosis or treatment plan which indicates root canal treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Maxillary anterior tooth or premolar with a diagnosis or treatment plan which indicates root canal treatment
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
Intranasal Anesthesia
Two intranasal sprays of tetracaine HCl and oxymetazoline HCl nasal spray anesthetic administered 4 minutes apart into the nostril corresponding to the side of the treated tooth. If inadequate anesthetic response obtained within 10 minutes, a third spray will be administered and assessed for effective anesthesia after 4 minutes.
干预措施: Tetracaine HCl and oxymetazoline HCl nasal spray (Drug)
结局指标
主要结局
Proportion of patients that are successfully anesthetized for endodontic treatment
时间窗: From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)
Anesthetic success is defined as having sufficiently anesthetize teeth to allow for endodontic treatment.
次要结局
- Proportion of patients demonstrating sufficient pulpal anesthesia to commence treatment(From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours))
- Proportion of premolars vs. anterior teeth successfully anesthetized(From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours))
- Stage of anesthesia failure(From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours))
- Time of anesthesia failure after completion of anesthetic administration(From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour))