2023-508216-29-00招募中3 期
Prospective double-blind randomized comparative study of the use of methoxyflurane vs placebo in the management of pain in oral and dental emergencies in adults: METODO (METhoxyflurane in ODOntology)
Centre Hospitalier Regional Et Universitaire De Brest1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2024年3月18日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10
研究概览
简要总结
The main aim of this study is to evaluate the efficacy of methoxyflurane (Penthrox®) in the management of pain in oral emergencies.
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
- 否
入选标准
- •Adult patient (> 18 years)
- •Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NPS greater than or equal to 4
- •Patient has social security affiliation or who beneficiary of such social security
- •Patients who have given informed consent
排除标准
- •Patients with a history of allergy to methoxyflurane or any of the components of Penthrox (take into account family history of severe allergic reactions)
- •Patients with a history of malignant hyperthermia (known or genetic predisposition)
- •Patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia
- •Patients with severe renal failure
- •Patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse
- •Patients with cardiovascular instability or respiratory depression
- •Pregnant or breast-feeding patients. Therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study
- •Patients under legal protection (guardianship and curatorship) or deprived of liberty
- •Patients unable to speak or read French fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests
结局指标
主要结局
The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10
The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10
次要结局
- Pain intensity <4/10 (yes/no) at T=15min after treatment
- Measurement of pain intensity at T=7min (immediate efficacy)
- Measurement of pain intensity at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)
- Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale)
- Report adverse events in both groups
- Measuring the amount of local anesthetic used during treatment
- Post-care satisfaction questionnaire
- Measurement of pain intensity at T=15min according to analgesic associated with methoxyflurane
- Measurement of pain intensity at T=15min according to type of emergency
研究者
Prof. BOISRAME Sylvie
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (1)
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