The Use of Ketorolac in Surgical Neonates
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety from bleeding events.
研究概览
简要总结
The general purpose of this study is to characterize the safety profile of ketorolac in infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9% normal saline as placebo.
Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.
Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.
详细描述
This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients one week of age to 3 months of age who undergo an abdominal surgical procedure within the moderate or severe degree of pain category (see attached Table 1: postoperative pain categories) will be randomized to receive standard pain management regimens plus placebo (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain management regimens. The postoperative management will be unchanged and at the discretion of the attending surgeon, as appropriate for the surgical procedure. The patients will be followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary endpoints.
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
- 1 Week 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants gestational age > 37 weeks and greater than or equal to one week of age to 3 months of age
- •Infants who are undergoing a surgical procedure on the abdomen
- •the parent or guardian has given informed consent.
排除标准
- •Gestational age < 37 weeks
- •Age less than one week or greater than 3 months of age
- •Known renal disease/dysplastic kidneys
- •Serum Creatinine > 0.4
- •Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)
- •Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa [except for use of thrombosed central venous catheters], enalapril, systemic heparin [except for use in central venous catheter flushes])
- •Patients who undergo nephrectomy
- •Patients with necrotizing enterocolitis
- •Patients with a hemoglobin value < 10g/dL
- •Recent (within 3 months) GI bleeding, ulceration, and/or perforation
- •Platelet count < 50,000
- •Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage
- •Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)
- •Allergy to ASA or other NSAIDS
研究组 & 干预措施
Placebo
Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.
干预措施: placebo (Drug)
Ketorolac
Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Safety from bleeding events.
时间窗: 5 days
Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. We hypothesize that ketorolac is safe and effective in infants \> 37wks gestation and at least one week of age.
次要结局
- Clinical parameters related to pain.(5 days)