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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment
研究概览
简要总结
With a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. Pain is the main reason for consultation, and is particularly exacerbated in the orofacial sphere. Dental pain has several etiologies: infectious, inflammatory or traumatic accidents.Beyond the ethical aspects of acute pain management, pain relief is a real objective. Despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. Numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. To meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (Penthrox®) could be considered. This product, mainly intended for emergency services, has been approved in Europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". Thus, it would be interesting to assess the value of methoxyflurane (Penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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 NRS 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
研究组 & 干预措施
Experimental group
干预措施: Experimenta group (standard of care + Methoxyflurane). (Drug)
control group
干预措施: control group (standard of care + placebo). (Drug)
结局指标
主要结局
Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment
时间窗: 15 minutes post-treatment
Pain at baseline and at T=15min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
次要结局
- Measuring the amount of local anesthetic used during treatment(1 day)
- Pain intensity <4/10 (yes/no) at T=15min after treatment(15 minutes post-treatment)
- Pain assessed by a numerical rating scale at T=7min (immediate efficacy)(7 minutes post-treatment)
- Pain assessed by a numerical rating scale at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)(40 minutes post-treatment)
- Assessment of Anxiety(Just before chairside treatment)
- Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane(15 minutes post-treatment)
- Pain assessed by a numerical rating scale at T=15min according to type of emergency(15 minutes post-treatment)
- Post-care satisfaction questionnaire(End of the study (up to 1 day))