Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mean dynamic VAS
研究概览
简要总结
The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy
详细描述
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.
A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult (40-65 years)
- •ASA I-II women
- •scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy
排除标准
- •renal impairment,
- •allergy to any of study's drugs,
- •history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
- •severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
- •patients undergoing surgery for suspected gynaecological cancer,
- •patients on chronic analgesic medication,
- •inability to comprehend the Visual Analogue Pain Scoring Scale
研究组 & 干预措施
Ketorolac group
ketorolac 30 mg
干预措施: Ketorolac Injectable Solution (Drug)
Ibuprofen group
ibuprofen 800 mg
干预措施: Ibuprofen 800 mg (Drug)
结局指标
主要结局
mean dynamic VAS
时间窗: 24 hour after surgery
average postoperative VAS
次要结局
- static VAS(30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively)
- dynamic VAS(procedure (during knee flexion))
- patients satisfaction(at the end of 24 hour postoperative)
- time to first analgesia requirement(period from extubation until first analgesic requirement during the first 24 hour postoperatively)
- morphine consumption(during the first 24 hour postoperatively)
- time to independent movement(during the first 24 hour postoperatively)
研究者
Ahmed Hasanin
Principal Investigator
Cairo University