Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 主要终点
- Adverse drug reactions (questionnaire)
研究概览
简要总结
The objective of this study is compare adverse reactions associated with oxycodone and morphine for the treatment of postoperative pain after abdominal hysterectomy
详细描述
A randomized single-blind study, was performed to compare the adverse reactions associated with oxycodone and morphine in patients undergoing abdominal hysterectomy.
process:
- A clinical history of patients candidates to participate in the study will be developed.
- If you meet the selection criteria will be held the invitation to participate in the study, reading the letter under information
Patients who agree to participate in the study will be managet during the surgical procedure:
15 mg mixed blockade with bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg intravenously during surgery metamizol 3) After the surgical procedure (immediate postoperative)
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for abdominal hysterectomy
- •Signing for informed consent
排除标准
- •Patients used with MAO inhibitor drugs (<14 days before surgery)
- •History of substance abuse
- •Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine)
- •Pretreatment of any opioid (<7/2 lives of the drug in question)
- •Chronic pain of any etiology (> 6 months)
- •Diagnosis of bowel obstruction
- •Renal or hepatic insufficiency
- •Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism.
- •Patients requiring general anesthesia for surgical complications
研究组 & 干预措施
Morphine
Multimodal analgesia to morphine
干预措施: Morphine (Drug)
Oxycodone
Multimodal analgesia to oxycodone
干预措施: Oxycodone (Drug)
结局指标
主要结局
Adverse drug reactions (questionnaire)
时间窗: 24 hours
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
次要结局
- systemic blood pressure (mmHg) (physiological parameter)(24 hours)
- Postoperative pain (Numeric Pain Rating Scale)(24 hours)
- Heart rate (physiological parameter)(24 hours)
- Oxygen saturation (physiological parameter)(24 hours)
研究者
VIRGINIA ALEYDA SANCHEZ LOPEZ
MD Pharmacology
Hospital Civil de Guadalajara