Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
研究概览
简要总结
The aim is to investigate and to find a correlation between tramadol addiction misuse among Algerian males and Dental Local Anesthesia success while performing dental care and oral surgeries.
详细描述
Local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. Since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. Hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner.
The intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. These drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as Tramadol.
Tramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. It is 4-phenyl-piperidine analogue of the opioid drug codeine. It is generally well tolerated with few and rare side effects. Moreover, comparative studies have mostly shown that Tramadol is more effective than NSAIDs for post operative pain control. However, its misuse is increasingly growing and has become obvious in Algeria.
Tramadol addiction has become very frequent, and its unjustified use is expanding. This might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants.
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
- Single (Care Provider)
盲法说明
Dentists providing dental care participating in the study are masked.
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
- 是
入选标准
- •≥18 years old <65
- •Without comorbid conditions (Hypertension, diabetes, Asthma etc..)
- •Tramadol addicted (regular tramadol user)
- •Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded.
排除标准
- •˂ 18 years old
- •With comorbid conditions (HTN, diabetes, epilepsy etc..)
- •≥ 65 years old men.
- •Not addicted to tramadol or addicted to other drugs with it.
结局指标
主要结局
Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
时间窗: 3 months
The quantity (ml) of dental anesthesia used to perform dental and oral surgery procedure among tramadol addicted and non-addicted patients will be mesured to investigate the difference.
To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
时间窗: 3 months
Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.
次要结局
- To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.(3 months)
研究者
Mohammed Amir Rais
Principal Investigator
University of Algiers