NCT06479122招募中4 期
Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Obstetric QoR-11K score 24 hours after end of surgery
研究概览
简要总结
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective cesarean section
- •Gestational age > 37+0 weeks
排除标准
- •Emergency cesarean section
- •Multiple pregnancy (e.g. twins, triplets)
- •Body weight < 50 kg
- •Preeclampsia
- •History of hypersensitivity to acetaminophen or ibuprofen
- •History of upper gastrointestinal tract bleeding or gastric ulcer
- •Underlying liver disease
- •Underlying kidney disease or GFR < 90 mL/min/1.73m2
- •Heart failure or severe hypertension
- •History of asthma
- •Chronic use of barbital or tricyclic antidepressants
研究组 & 干预措施
Acetaminophen/Ibuprofen
Experimental
干预措施: Acetaminophen/Ibuprofen (Drug)
Acetaminophen
Active Comparator
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Obstetric QoR-11K score 24 hours after end of surgery
时间窗: 24 hours after end of surgery
Minimum 0, poor recovery; maximum 110, good recovery
次要结局
- Anesthesia time(Duration of anesthesia)
- Numeric rating scale pain score (0-10) 4 hours after end of surgery(4 hours after end of surgery)
- Numeric rating scale pain score (0-10) 8 hours after end of surgery(8 hours after end of surgery)
- Numeric rating scale pain score (0-10) 48 hours after end of surgery(48 hours after end of surgery)
- Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery(48 h after end of surgery)
- Use of rescue analgesia during the first 48 hours after end of surgery(48 h after end of surgery)
- Operation time(Duration of operation)
- Injection level of intrathecal drug(After arrival at the operating room)
- Dosage of intrathecal drug (mg, bupivacaine)(After arrival at the operating room)
- Sensory blockade level by time point(0, 5, 10 minutes after intrathecal injection and at the end of operation)
- Numeric rating scale pain score (0-10) 12 hours after end of surgery(12 hours after end of surgery)
- Numeric rating scale pain score (0-10) 24 h after end of surgery(24 h after end of surgery)
- Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery(24 h after end of surgery)
- Use of rescue analgesia during the first 24 hours after end of surgery(24 h after end of surgery)
- Wound-related complications during hospital stay, up to 5 days(From end of surgery to patient discharge, up to 5 days)
研究者
Jeong-Hwa Seo
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Determine the Clinical Advantage of IV vs PO AcetaminophenInguinal HerniaNCT03558555Yan Lai103
已完成
不适用
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate RepairCleft PalateNCT01500109Loma Linda University45
已完成
4 期
Intravenous Versus Oral Acetaminophen in Primary Total Hip ArthroplastyArthroplasty, Hip ReplacementAcetaminophenOsteoarthritisNCT02839876Duke University81
已完成
4 期
Efficacy of IV Acetaminophen Versus Oral AcetaminophenNephrectomyNCT03365622University of Rochester214
已完成
不适用
Comparison of intravenous acetaminophen and pethidine in pain renal colicRenal Colic.Calculus of kidney and ureterIRCT2016090429690N1Vice chancellor for research, Ardabil University of Medical Sciences100