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临床试验/NCT05793905
NCT05793905已完成4 期

Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars

Damascus University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Pulse rate

研究概览

简要总结

In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.

详细描述

In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. Random numbers between 1 to 40 were assigned to patients, with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine. The solutions have been switched up for the second session, which has been set for one week later. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2% lidocaine with 1:80,000 epinephrine. Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine 1/80.000) in a 1:10 ratio by volume. Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection (IANB). The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. After administering the IANB injection, the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain. Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds. The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective, objective, and physiological pain scales. Finally, the numerical data will be statistically analysed, and any statistically significant values will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple Masking: Patients, Investigators and Statistician

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.
  • Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).
  • Children aged 6-10 years old
  • Cooperative children on Frankel scale (positive or absolute positive).
  • children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.
  • A positive outcome on the cold test for the target tooth.

排除标准

  • Uncooperative children on Frankel's scale (passive or absolute positive).
  • The presence of a fistula.
  • The presence of an abscess associated with the target tooth.
  • The presence of a periapical lesion radially.
  • Negative response to the cold test.
  • Children suffering from systemic conditions.
  • Children who are allergic to (lidocaine, adrenaline, sodium bicarbonate).

研究组 & 干预措施

Buffered lidocaine

Experimental

Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%)

干预措施: Buffered lidocaine in inferior alveolar nerve block injection (Combination Product)

Lidocaine 2%

Other

Control group:

Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000).

干预措施: lidocaine 2% in inferior alveolar nerve block injection (Drug)

结局指标

主要结局

Pulse rate

时间窗: 20 seconds after the first quarter of the local anaesthesia.

Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.

Probing the gingiva

时间窗: directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.

The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.

Sound, eye, motor scale (SEM)

时间窗: Within five seconds from the start of the local anesthetic injection to completion

Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia

Endo - ice test

时间窗: Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.

The investigator will use endo-ice to assess the onset time of pulp anaesthesia.

Wong baker faces scale.

时间窗: One minute after IANB injection

Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"

次要结局

  • Pulse rate(20 seconds after opening the pulp chamber)
  • Wong baker faces scale(one minute after preparing pulp chamber)
  • sound, eye, motor scale (SEM)(Within five seconds from the start of the local anaesthetic injection to completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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