Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Narcotic Requirement After Surgery
研究概览
简要总结
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.
To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.
To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 45 kg (amenable to adult dosing)
- •all traumatic brain injuries NPO for at least 12 hours
- •all post-operative craniotomy patients
- •all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
- •all carotid endarterectomy and carotid artery stenosis patients
- •all endovascular patients undergoing intracranial intervention
- •all post-op spine patients admitted to the NCCU
排除标准
- •documented allergy to acetaminophen
- •documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
- •documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
- •patients who are pregnant or breast feeding
研究组 & 干预措施
Intervention group
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
干预措施: Intravenous acetaminophen (Drug)
Placebo Group
IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
干预措施: Placebo for IV acetaminophen (Drug)
结局指标
主要结局
Narcotic Requirement After Surgery
时间窗: 48 hours
The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.
次要结局
未报告次要终点