Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The goal of this randomized, triple-masked clinical trial is to compare the effectiveness and safety of the use of ibuprofen versus dipyrone for postoperative analgesia in postpartum women with preeclampsia undergoing cesarean section.
The main question it aims to answer are:
- Postoperative pain is similar;
- The frequency of acute kidney injury is similar.
Researchers will compare one group that will receive dipyrone and the other group that will receive ibuprofen to see if Postoperative pain are different between groups or development of acute kidney injury each group is different.
详细描述
Specific objectives
In postpartum women with preeclampsia undergoing cesarean section randomized to receive treatment with ibuprofen versus dipyrone for postoperative analgesia, compare:
primary outcomes
- Postoperative pain (mild, moderate, severe by visual analogue scale)
- Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/ hour for six to 12 hours).
secondary outcomes
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Puerperal women from 14 years of age diagnosed with preeclampsia with signs of severity Immediate postoperative period;
- •Delivery attended at the Maternity from Instituto de Medicina Integral Prof Fernando Figueira.
排除标准
- •Acute kidney disease (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/hour for six to 12 hours)
- •Chronic kidney disease;
- •Diabetes mellitus;
- •Collagenoses;
- •Sickle cell anemia;
- •Patients who presented bleeding in the pre, trans and immediate postpartum periods;
- •Antepartum or puerperal sepsis;
- •Known contraindications to the use of NSAIDs and dipyrone;
研究组 & 干预措施
Group 1
Ibuprofen 400mg 6/6h, oral, maximum 5 days
干预措施: medication 1 (Drug)
Group 2
Dipyrone 1g 6/6h, oral, maximum 5 days
干预措施: medication 2 (Drug)
结局指标
主要结局
Postoperative pain
时间窗: from 24 after delivery to 48 hours
Postoperative pain (mild, moderate, severe by visual analogue scale)
Development of acute kidney injury
时间窗: from 24 after delivery to 48 hours
Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to \<0.5 mL/kg/ hour for six to 12 hours).
次要结局
- Allergic reactions(from 24 after delivery to 48 hours)
- Time between postoperative and unassisted ambulation(from 24 after delivery to 48 hours)
- Mean reduction of pain scores by visual analogue scale;(from 24 after delivery to 48 hours)
- Mean reduction in pain scores assessed by algometer(from 24 after delivery to 48 hours)
- need for rescue analgesic therapy;(from 24 after delivery to 48 hours)
- User satisfaction level(from 24 after delivery to 48 hours)
- urea dosage(from admission in the hospital until 48 hours after delivery)
- aspartate transferase dosage(from admission in the hospital until 48 hours after delivery)
- potassium dosage(from admission in the hospital until 48 hours after delivery)
- chlorine dosage(from admission in the hospital until 48 hours after delivery)
- alanine transferase dosage(from admission in the hospital until 48 hours after delivery)
- lactic dehydrogenase dosage(from admission in the hospital until 48 hours after delivery)
- sodium dosage(from admission in the hospital until 48 hours after delivery)
- creatinine dosage(from admission in the hospital until 48 hours after delivery)
- c(from admission in the hospital until 48 hours after delivery)
- total and fractions bilirubin dosage(from admission in the hospital until 48 hours after delivery)
- uric acid dosage(from admission in the hospital until 48 hours after delivery)
- Evolution of blood pressure in the puerperium(from 24 after delivery to 48 hours)
- Number of hypertensive peaks(from 24 after delivery until discharge of the hospital)
- need for maintenance antihypertensive treatment(from 24 after delivery until discharge of the hospital)
- Length of hospital stay(From hospital admission to hospital discharge date or up to eight days after surgery whichever comes first.)
- number of antihypertensive drugs;(from 24 after delivery until discharge of the hospital)
- Maternal death(from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.)
- Gastrointestinal side effects(from 24 after delivery to 48 hours)
- Compound maternal morbidity(from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.)
- Costs related to analgesic medications(from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.)
研究者
Leila Katz
MD PhD
Instituto Materno Infantil Prof. Fernando Figueira