Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section
研究概览
简要总结
This is a randomized controlled single blinded trial to compare the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
详细描述
Administration of a dose of ketorolac for postoperative pain management at end of cesarean is routine practice at our institution.
This is a randomized controlled single blinded trial at The Ohio State University comparing a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room immediately after cesarean section.
Potential study participants will be identified at the time of admission to Labor and Delivery unit. Inclusion criteria must be met, namely patient's age, mode of delivery via cesarean section. The decision for mode of delivery will be at the discretion of the primary obstetrics (OB) provider. Indications for cesarean delivery would be: scheduled cesarean due to history of previous uterine surgery including prior cesarean section, failed induction of labor, arrest of second stage of labor, non-reassuring fetal status.
Patients will be approached for consent and enrollment when decision is made to proceed for cesarean section by their primary provider. Patients with allergy to Non-steroidal anti-inflammatory drugs (NSAIDs), history of opioid use disorder, chronic pain disorders, or undergoing an emergent Cesarean section, will be excluded from the study.
Once the decision has been made by the primary obstetrics (OB) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups:
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
- Single (Participant)
盲法说明
Single blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy
- •Cesarean section as the delivery mode
- •Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural)
排除标准
- •Known allergy or adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or ketorolac
- •Patients with peptic ulcer disease, preexisting kidney or liver disease
- •Hemodynamically unstable due to hemorrhage
- •Acute or chronic pain disorder
- •Physician/provider or patient refusal
- •Estimated blood loss > 2000 mL
- •General anesthesia
- •Opioid use disorder
- •Emergent Cesarean delivery
- •Coagulation disorders
- •Active asthma
- •Patients weighing <50 kg
研究组 & 干预措施
Ketorolac 30 mg
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
干预措施: Ketorolac 30 Mg (Drug)
Ketorolac 60 mg
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
干预措施: Ketorolac 60 Mg (Drug)
结局指标
主要结局
Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section
时间窗: After cesarean surgery up to 24 hours.
Comparing the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
次要结局
- Comparing the Morphine Milligram Equivalents (MME) Use During Hospital Stay.(After cesarean surgery during hospital stay up to 2-3 days.)
- Comparing Patient Reported Pain Score Assessment.(After cesarean surgery up to 24 hours.)
- Comparing the Time to First Administration of Opioid Pain Medication Postoperatively.(After cesarean surgery up to 2-3 days.)
- Pain Score on Discharge Home(After cesarean surgery during hospital stay up to 2-3 days.)
- Number of Participants With Adverse Maternal Outcomes.(After cesarean surgery during hospital stay up to 2-3 days.)
- Evaluating Type of Skin Incision.(After cesarean surgery during hospital stay up to 2-3 days.)
研究者
Kara M Rood, MD
Assistant Professor
Ohio State University