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临床试验/NCT04349397
NCT04349397Unknown不适用

Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Total opioid administered during POD 1-5 (converted to morphine dose equivalents)

研究概览

简要总结

The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.

详细描述

You and your child will be enrolled into the study during your child's scheduled surgery at DCH. Your child's surgery, anesthesia plan, and recovery will not change because of your participation in this study. Following discharge from the hospital, the study team will give you two follow-up phone calls that will take approximately 15 minutes. During these phone calls, we will ask you about your child's pain, any nausea or vomiting that has occurred, your child's intake of liquid and food, your child's activity level, and the medications they have been given over the course of the 5 days post-operation. Along with talking over the phone, we will ask you to document this information. After the post-operation day 6 phone call, you and your child will not be asked any additional questions for research purposes and we will ask you to return any documents you were given by the study team. Within 30 days of your and your child's participation in the study, the research team will pull medical information from your child's electronic medical record. Your child's electronic medical record will be reviewed to obtain demographic information such as date of birth, age, weight, ethnicity, medical history, and status information will also be collected such as allergies, potential complications, any pain scores collected during your child's post-anesthesia care unit (PACU) stay, and medical visits. 30 days after your child's surgery, you and your child will no longer be enrolled in this research study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes or Parent or guardian of a child aged 3-12 years old that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes

排除标准

  • 未提供

结局指标

主要结局

Total opioid administered during POD 1-5 (converted to morphine dose equivalents)

时间窗: POD 1-5

Total amount of opioid analgesics administered at home on Post-operative days 1-5.

次要结局

  • Duration of impaired activity(POD 1-5)
  • Mean Worst Pain Scores POD 1-5(POD 1-5)
  • Total acetaminophen administered on POD 1-5(POD 1-5)
  • Total ibuprofen administered on POD 1-5(POD 1-5)
  • Duration of impaired drinking(POD 1-5)
  • Duration of impaired eating(POD 1-5)
  • Frequency of Vomiting on POD 1-5(POD 1-5)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Martin

Principal Investigator

Oregon Health and Science University

研究点 (1)

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