The Efficacy of Intravenous Acetaminophen During The Perioperative Period Of Neurosurgical Patients Undergoing Craniotomies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Opioid Requirement After Surgery
研究概览
简要总结
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.
The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery.
Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
详细描述
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.
The following information will be recorded for each patient enrolled in this study:
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Patient information/Preoperative Data
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Age, sex, height, weight,
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Disease specific information
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Primary diagnosis
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Pertinent medical history
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Medications
-
Pertinent changes in patient status
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Procedural information
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Operation type
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Preoperative anesthetic medications
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Induction meds, intra-operative anesthetic meds, and post-operative anesthetic meds
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Duration of Surgery and Intubation
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Amount of dilaudid equivalent narcotics
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Postoperative Information
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject are able to provide informed consent prior to participation in the study
- •Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour duration
- •Subjects must be >18 years old but less than 90 years old
- •Subjects must have an American Society of Anesthesiologists (ASA) class I-IV
- •Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales
排除标准
- •Subjects used opioids or tramadol daily for >7 days before study medication administration
- •Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian
- •Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare
- •Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients
- •Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery
研究组 & 干预措施
Acetaminophen
Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.
干预措施: Acetaminophen (Drug)
Placebo
Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.
干预措施: Placebo (Drug)
结局指标
主要结局
Opioid Requirement After Surgery
时间窗: during first 24 hours after surgery
The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline).
次要结局
- Time to Rescue Medication in Both Groups(0 to 24 hours after surgery)
- Amount of Rescue Medication in PACU in Both Groups(0 to 24 hours after surgery)
- Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups(from 0 to estimated 24 hours after surgery)
- Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No(from 0 to estimated maximum of 24 hours after surgery)
- Median Difference in Temperature Between Intervention and Placebo Groups(from 0 to estimated maximum 24 hours after surgery)
- Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups(during first 24 hours after surgery)
- Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups(during first 24 hours after surgery)
- # of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups-(during first 24 hours after surgery)
- Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied)(During first 24 hours after surgery)