Measuring Pain and Hydration After Tonsillectomy
Primary Purpose
Dehydration
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hoist Group
Sponsored by
About this trial
This is an interventional treatment trial for Dehydration focused on measuring Dehydration, Hoist, pain control, The intervention is to provide a commercially available isotonic hydration solution (Hoist®) to the patients., Patients will drink this solution post procedure as needed., Patients in the control group will use their discretion to drink any solution they feel suitable
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing tonsillectomy
- Patients undergoing tonsillectomy with adenoidectomy
Exclusion Criteria:
- Patients on anticoagulants
- Patients younger than 3 years old
- Patients with chronic pain syndrome
Sites / Locations
- Queen City ENT
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Hoist
Arm Description
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
Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer
Outcomes
Primary Outcome Measures
Incidence of dehydration
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.
Secondary Outcome Measures
Patient reported pain level
Patients will take a survey for up to 10 days after tonsillectomy to rate their level of pain each day. This will be used to see a correlation between reported pain level and amount of fluid intake each day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02011230
Brief Title
Measuring Pain and Hydration After Tonsillectomy
Official Title
Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
IRB closed study: irregularities in documentation of informed consent, HIPAA
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TriHealth Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
Dehydration, Hoist, pain control, The intervention is to provide a commercially available isotonic hydration solution (Hoist®) to the patients., Patients will drink this solution post procedure as needed., Patients in the control group will use their discretion to drink any solution they feel suitable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Hoist
Arm Type
Experimental
Arm Description
Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer
Intervention Type
Other
Intervention Name(s)
Hoist Group
Other Intervention Name(s)
Hoist
Intervention Description
Hoist is a commercially available drink that is sold locally. This solution is isotonic meaning that it contains similar concentrations of salt and sugar that are found in the human body
Primary Outcome Measure Information:
Title
Incidence of dehydration
Description
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.
Time Frame
0-10 days
Secondary Outcome Measure Information:
Title
Patient reported pain level
Description
Patients will take a survey for up to 10 days after tonsillectomy to rate their level of pain each day. This will be used to see a correlation between reported pain level and amount of fluid intake each day
Time Frame
0-10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing tonsillectomy
Patients undergoing tonsillectomy with adenoidectomy
Exclusion Criteria:
Patients on anticoagulants
Patients younger than 3 years old
Patients with chronic pain syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Schwetschenau, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen City ENT
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study terminated
Learn more about this trial
Measuring Pain and Hydration After Tonsillectomy
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