Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
研究概览
简要总结
To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
详细描述
This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The subjects, care providers, and investigators will be blinded to the assignments of groups.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
- •The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
- •The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.
排除标准
- •Patients with allergy to ketorolac, NSAIDS or aspirin
- •Patients with peptic ulcer disease, preexisting kidney or liver disease.
- •Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
- •Patient is hemodynamically unstable due to hemorrhage.
- •Patient requires therapeutic anticoagulation in the post-operative period
- •Patients with peripartum cardiomyopathy
- •Provider decision to exclude patient.
- •Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
- •A study subject may participate in another research study while participating in this research study.
研究组 & 干预措施
Ketorolac Protocol
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit.
干预措施: Ketorolac (Drug)
结局指标
主要结局
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
时间窗: Within 72 postoperative hours
The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization.
次要结局
- Number of Participants With a Pain Score Greater Than 3(2 weeks)
- The Number of Patients That Used no Opioid Postoperatively(Within 72 post-operative hours)
- Postoperative Change in Hematocrit(Change in pre-operative hematocrit to POD1 hematocrit)
- Change in Creatinine(Change in creatinine from POD1 to POD2)
- Postoperative Satisfaction With Inpatient Pain Control(Inpatient pain control satisfaction as reported at two weeks postpartum)
- Postoperative Satisfaction With Their Inpatient Postpartum Care.(Satisfaction with inpatient care as reported at two weeks postpartum)