Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- postpartum antihypertensive requirements
研究概览
简要总结
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.
详细描述
Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions.
The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at > 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
- •An antepartum diagnosis of preeclampsia with severe features
- •Pre-eclampsia with severe features will be defined as:
- •Elevated blood pressure ≥ 160/110, or
- •Pre-eclampsia in the setting of thrombocytopenia (platelet count < 100,000), or
- •Impaired liver function (AST elevated to twice upper limit of normal), or
- •Persistent epigastric pain, or
- •Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or
- •Pulmonary edema, or
- •New onset visual disturbance or headache unresponsive to therapy.
排除标准
- •NSAID allergy
- •Allergy to acetaminophen
- •Antihypertensive use in this pregnancy prior to 20 weeks gestation
- •Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
- •Inability to obtain consent
- •Opioid abuse disorder
- •Peptic ulcer disease.
研究组 & 干预措施
NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
干预措施: Acetaminophen (Drug)
NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
干预措施: Ibuprofen 600 mg (Drug)
NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
干预措施: Oxycodone (Drug)
NSAID free analgesic bundle
Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.
干预措施: Acetaminophen (Drug)
NSAID Analgesic bundle
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
干预措施: Ketorolac (Drug)
NSAID free analgesic bundle
Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.
干预措施: Oxycodone (Drug)
结局指标
主要结局
postpartum antihypertensive requirements
时间窗: at the end of hospitalization, up to 7 days after randomization
measurement of anti-hypertensive requirements at time of discharge
次要结局
- End organ damage(during hospitalization, an average of 4 days)
- Postpartum pain scores(From randomization to 6 weeks after randomization)
- Hospital readmission(From randomization to 6 weeks after randomization)
- Postpartum opioid use(From randomization to 6 weeks after randomization)
- Mean arterial blood pressure(From randomization to 6 weeks after randomization)
- Continued anti-hypertensive requirement(up to 6 weeks)