跳至主要内容
临床试验/NCT02011230
NCT02011230终止不适用

Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
57
试验地点
1
主要终点
Incidence of dehydration

研究概览

简要总结

Pain after tonsillectomy remains a key barrier during the post operative period. The published return rate to the emergency department for hydration and pain control is approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency department post tonsillectomy, patient experiences will be improved and health care dollars spent will be decreased. We will attempt to improve hydration status by encouraging consumption of a novel isotonic hydration solution that is currently commercially available.

Our study hypothesis is that patients provided an isotonic hydration solution and instructions on avoiding dehydration post operatively will have improved pain control and decreased emergency department visits.

Improvement in hydration status has the potential of decreasing emergency room visits and subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative hydration may include decrease in pain and decrease in post-operative bleeding rates.

A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently become commercially available. Itis very similar to that of Pedialyte, a commonly used rehydration solution. Pedialyte was designed for rehydration of infants and small children. It has a taste that is not acceptable to many adults and older children.

This study will implement the use of Hoist as suitable rehydration solution. This study is designed to define the relationship between improvement of patient's hydration through provision of a rehydration solution during the post operative period and decrease in complications requiring return to the emergency room, including dehydration and bleeding, as well as improvement in overall pain control.

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
4 Years 至 98 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing tonsillectomy
  • •Patients undergoing tonsillectomy with adenoidectomy

排除标准

  • •Patients on anticoagulants
  • •Patients younger than 3 years old
  • •Patients with chronic pain syndrome

研究组 & 干预措施

Control

No Intervention

Patients in the control group will not be given any special fluids to take after surgery Patients will use their discretion to drink as needed following surgery

Hoist

Experimental

Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer

干预措施: Hoist Group (Other)

结局指标

主要结局

Incidence of dehydration

时间窗: 0-10 days

Patients in the Hoist group will be given a 10 day supply of Hoist (22 bottles). Patients will self-administer the Hoist solution (Parents will administer the Hoist in the case of minor study participants) Pain will be measured during the recovery phase for ten days. Patients will be asked to rate their pain level each day post op (days 0-10) using a numeric pain intensity scale in addition, children ages 4-12 will also receive a Wong-Baker FACES pain scale.

次要结局

  • Patient reported pain level(0-10 days)

研究者

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

Angela N Fellner PhD CCRP

Clinical Research Specialist

TriHealth Inc.

研究点 (1)

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