The Outcome of CYP2D6 Polymorphism on Tramadol Analgesia in Postpartum Patients in Erbil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual analog scale (10 cm)
研究概览
简要总结
CYP2D6 is an enzyme involved in the hepatic metabolism of many clinically important drugs: antiarrhythmics, antidepressants, antipsychotics, β-blockers, and analgesics such as tramadol and codeine. CYP2D6 is highly polymorphic and significant interindividual variability has been observed worldwide. This study aims to investigate the distribution of CYP2D6 polymorphisms among post-cesarean female patients in Erbil city, Iraq. The findings of this study may indicate the presence of CYP2D6 gene variants among the Kurdish female population in Erbil, which could contribute to tramadol analgesic failure or exaggerated adverse effects. This study could also serve as a foundation for further pharmacogenetic research, individualizing treatments and targeting a larger sample size in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18-50 years old
- •Patients who are indicated to undergo elective cesarean section surgery
- •Patients that are indicated to receive tramadol drug for postpartum pain management
排除标准
- •Patients with any history of severe renal, liver, respiratory diseases and/or seizures
- •Patients with history of psychiatric disorders or unable to provide consent
- •Patients with complicated surgeries or neonatal distress or unable to perform the clinical assessment of pain
- •Patients with history of consumption of chronic alcohol or opioid or drug abuse
- •Patients with history of known allergy to tramadol
研究组 & 干预措施
post-cesarean patients
All of these patients were planned to undergo elective cesarean surgery and receive postpartum management for twenty-four hours at the Erbil Maternity and Childbirth Hospital. Consent was taken from each patient prior to the enrollment into the study. Their age ranged between 21-42 years. Patients received one dose of tramadol drug (100mg/2ml of Trodon® Hemofarm) intravenously for management of postpartum pain after gaining back their pain sensation.
干预措施: Trodon® Hemofarm (Drug)
结局指标
主要结局
Visual analog scale (10 cm)
时间窗: after 1 hour and 6 hours of receiving single dose of tramadol
Visual analog scale is used for measuring pain intensity on a scale of 0 to 10, in which a score on the line is marked by each patient ranging from "no pain" to "worst pain". The pain intensity increases as the score on the scale goes up.
次要结局
- Blood pressure (mm of Hg)(after 1 hour and 6 hours of receiving single dose of tramadol)
- Heart rate (beats per minute)(after 1 hour and 6 hours of receiving single dose of tramadol)
- Oxygen saturation (SPO2%)(after 1 hour and 6 hours of receiving single dose of tramadol)
- Nocturnal pain(after 24 hours of receiving single dose of tramadol)
- Dietary state(after 24 hours of receiving single dose of tramadol)
- Adverse effects(after 1 hour and 6 hours of receiving single dose of tramadol for recording any adverse effects, and after 24 hours of receiving single dose of tramadol for evaluation of the bowel movement (whether the patient was constipated).)
研究者
Shaymaa Faruq Hamadameen
Research Investigator
Elweyia Maternity Teaching Hospital