2024-515965-32-00已完成2 期
Randomised, double-blind study comparing the analgesic efficacy of a lidocaine-prilocaine combination with lidocaine alone as local anesthesia for dental procedures in participants with MC1R mutation
Pharmavax AS1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年11月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
研究概览
简要总结
To investigate the analgesic efficacy of a lidocaine-prilocaine combination compared to lidocaine alone in dental procedures.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥18 and ≤
- •Written informed consent to participate in the study.
- •Participants with red hair or with at least one parent and/or grandparent with red hair and/or genetic sibling from same parents with red hair.
排除标准
- •History or presence of hypersensitivity or allergy to lidocaine (or prilocaine or other local anesthetics (amid type or sodium metabisulfite), a history of anaphylactic or anaphylactoid reactions, or a history of other allergy that, in the opinion of the investigator, contraindicates participation.
- •Participants with known thyrotoxicosis.
- •Participants with severe heart disease, including tachycardia.
- •Local infection in the area of injection.
- •Participants with congenital or idiopathic methemoglobinemia.
结局指标
主要结局
Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
次要结局
- Successful pulpal anaesthesia measured by the participants cold sensation during an ice test applied to the treated area.
- Subject’s assessment of successful soft tissue anaesthesia (yes/no) during a standard pocket procedure.
- Participant experience of anaesthesia on a scale from 1-5.
研究者
Co-ordinating investigator
Scientific
Pharmavax AS
研究点 (1)
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