Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in FLACC scale
研究概览
简要总结
68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. In the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment.
To assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment.
To assess the safety of this procedure, vital signs will be recorded before and after treatment.
Acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using Frankl scale.
If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.
详细描述
The most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. This approach carries several disadvantages. First is the child's fear of pain. Infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick.
Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist.
Importantly, patients' fear of injections can delay needed dental care. Surveys indicate that 30-40 million people in the US avoid going to the dentist because of fear of pain and anesthetic injections.
Therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. Further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.
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
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children between 7-10 years.
- •With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis.
- •Normal lip, nose, eyelid, and cheek sensation.
- •No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.
排除标准
- •Frequent bleeding form the nose (≥ 5 per month)
- •Inadequately controlled active thyroid disease of any type.
- •Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- •History of allergy to or intolerance of lidocaine or epinephrine.
研究组 & 干预措施
Nasal Spray of Lidocaine HCL
This group will receive treatment with an application of nasal spray for anesthetization.
干预措施: Nasal Spray of Lidocaine HCL (Drug)
Infiltration injection of Lidocaine HCL
Each patient in this group will receive an infiltration injection for anesthetization
干预措施: Infiltration injection of Lidocaine HCL (Drug)
结局指标
主要结局
Change in FLACC scale
时间窗: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
This scale will be used to evaluate efficacy. It will be studied by an external observer at 5 stages; first stage: during administration of the drug, second stage: while probing the gingiva around the tooth "buccally, palatally", third stage: when penetration of the dentino-enamel junction occurs, fourth stage: when exposure of the dental pulp occurs, fifth stage: during the removal of the coronal pulp.
Change in Blood Pressure
时间窗: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Systolic and diastolic blood pressure will be measured.
Change in Oxygen Saturation
时间窗: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Oxygen saturation will be measured using a specific device.
Change in Frankl scale
时间窗: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
This scale will be used to evaluate children's acceptance and will be measured by an external observer at five assessment times.
Change in Respiration Rate
时间窗: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Respiration rate will be measured clinically in the conventional manner.
Change in Heart Pulse Rate
时间窗: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Heart pulse rate will be measured clinically in the conventional manner.
次要结局
未报告次要终点