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临床试验/NCT05418504
NCT05418504Unknown4 期

Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males

Future University in Egypt2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年5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
入组人数
400
试验地点
2
主要终点
Anesthesia dose

研究概览

简要总结

Dental anesthesia is considered by far one of the main procedures in dentistry; the performance of a good dental anesthesia with a correct technique is paramount in controlling pain, facilitating the work of the dentist and gaining the confidence and cooperation of the patient

Tramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug

详细描述

Tramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug Meanwhile, apart from the systemic manifestations resulting from the abusive consumption of tramadol, it has become very clear that this opioid has a negative impact on the rapid and sufficient analgesic effect of dental anesthesia, it has been noticed that the anesthesia does not hold easily and the number of cartridges needed is increased, and therefore, a very particular attention must be attributed to the organization and control of its obtaining in order to limit its addiction in young people, an improvement of the care of patients must be offered according to the parameters necessary in the case of an addiction to tramadol

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • ≥18 years
  • With no comorbid conditions (HTN, Diabetes & Epilepsy)
  • Tramadol addict (regular tramadol user)

排除标准

  • ˂ 18 years
  • With comorbid conditions (HTN, Diabetes & Epilepsy)
  • ≥ 65 years males

研究组 & 干预措施

Non- Tramadol

Active Comparator

the control group represented by dental patients who are not a tramadol addict

干预措施: Dental anesthesia (Drug)

Tramadol

Active Comparator

The study group with patients seeking dental service but also are tramadol addict.

干预措施: Dental anesthesia (Drug)

结局指标

主要结局

Anesthesia dose

时间窗: 3 months

Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Mohamed Salah ElDin Diab ELBohy

Assisstant professor

Future University in Egypt

研究点 (2)

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