Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Post-operative pain scores
研究概览
简要总结
This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is age 3 to 10 years (inclusive)
- •The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
- •The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
- •The subject is ASA patient classification I-II
- •The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
排除标准
- •Additional surgical procedures are being performed concurrently;
- •The subject is ASA classification > II;
- •The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
- •The subject receives midazolam as a premedication;
- •The subject has a history of chronic malnutrition;
- •The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study
研究组 & 干预措施
IV Tylenol
Participants will receive IV acetaminophen 15mg/kg in the OR.
干预措施: Intravenous acetaminophen (Drug)
Normal Saline
Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen.
干预措施: Normal saline (Other)
结局指标
主要结局
Post-operative pain scores
时间窗: Every 5 minutes after awake in recovery room for 30 minutes
FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain
次要结局
- Quality of emergence from anesthesia(When first spontaneous eye movement occurs in recovery room)