Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE1)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose of Ketamine
研究概览
简要总结
The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.
详细描述
Pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. Current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. Recent evidence suggests that ketamine may provide successful post-surgical pain management, opioid reduction, and rapid reduction of depressive symptoms. The current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years and older
- •Cesarean Delivery
- •American Society of Anesthesiologists Physical Status of 2 or 3
- •Neuraxial anesthesia with neuraxial morphine
- •Term delivery ≥37 weeks gestation
- •Either planning not to breastfeed, OR receiving ketamine as part of routine clinical care
排除标准
- •General anesthesia
- •Allergy to study medications
- •ASA PS 4 or higher
- •Contraindications to neuraxial anesthesia
- •Preterm delivery (<37 weeks gestation)
- •Anticipated fetal-neonatal complex care plan
- •Participating in another pain intervention trial
- •Hypertensive disorder of pregnancy
- •Pre-eclampsia with severe features
- •Hemodynamic instability
- •Medical History exclusions: ketamine or PCP (phencyclidine) abuse, schizophrenia or psychosis, liver or renal insufficiency, uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled thyroid disease, or other contraindications to ketamine
研究组 & 干预措施
Ketamine (Ketalar) Dose Level 1
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
干预措施: Ketamine (Ketalar) Dose Level 1 (Drug)
Ketamine (Ketalar) Dose Level 2
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
干预措施: Ketamine (Ketalar) Dose Level 2 (Drug)
Ketamine (Ketalar) Dose Level 3
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
干预措施: Ketamine (Ketalar) Dose Level 3 (Drug)
Ketamine (Ketalar) Dose Level 4
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
干预措施: Ketamine (Ketalar) Dose Level 4 (Drug)
结局指标
主要结局
Maximum Tolerated Dose of Ketamine
时间窗: Between 0 to 24 hours postpartum
Maximum tolerated dose of ketamine is measured by dose that fewer than 33% of patients experience a dose-limiting toxicity (DLT) defined by intolerability. Tolerability will be defined as: lack of adverse events (adverse event defined as: severe unresolved hemodynamic effect: systolic blood pressure \<80 or \>160, heart rate \<40 or \>120). Intolerability will be defined as presence of any adverse event (i.e., severe unresolved hemodynamic effect: systolic blood pressure \<80 or \>160, heart rate \<40 or \>120). Outcome measure of tolerability and intolerability will be reported as n (%). The MTD was 0.18 mg/kg/hr for one hour, followed by 0.05 mg/kg/hr for 11 hours.
次要结局
- Patient Reported Acceptability of Any Reported Side Effects(Between 0 to 24-hours postpartum)
研究者
Grace Lim, MD, MS
Associate Professor, Chief Obstetric & Women's Anesthesiology
University of Pittsburgh