Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
详细描述
Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.
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
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English or Spanish speaker women who had a cesarean section
排除标准
- •Inability or refusal to provide informed consent.
- •Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
- •Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
- •Known alcoholism disorder.
- •Severe renal or hepatic impairment.
- •Known creatinine > 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery.
- •Severe peptic ulcer disease
- •Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate)
- •Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.
- •Allergy to any of the study drugs (anaphylaxis).
- •Incarcerated or institutionalized patients.
- •Inability to follow up as outpatient in our outpatient clinic.
- •wound dehiscence or infection diagnosed prior to discharge from the hospital
- •wound vac placed prior to discharge from the hospital
研究组 & 干预措施
ibuprofen plus acetaminophen
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
干预措施: Ibuprofen (Drug)
ibuprofen plus acetaminophen
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
干预措施: Acetaminophen (Drug)
ibuprofen plus acetaminophen/hydrocodone
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)
干预措施: Ibuprofen (Drug)
ibuprofen plus acetaminophen/hydrocodone
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)
干预措施: Norco (Drug)
结局指标
主要结局
Pain Level
时间窗: 2-4 weeks postpartum
pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.
次要结局
- Patient Satisfaction(2-4 weeks postpartum)
研究者
Jenifer Dinis Ballestas
MD, Maternal Fetal Medicine Fellow
The University of Texas Health Science Center, Houston