Back to resultsOutcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Primary Purpose
Chronic Tonsillitis, Sleep Disordered Breathing
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet modification
Sponsored by
About this trial
This is an interventional other trial for Chronic Tonsillitis
Eligibility Criteria
Inclusion Criteria:
- Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.
Exclusion Criteria:
-
Sites / Locations
- MedStar Georgetown University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Standard soft diet
Non-restricted diet
Arm Description
Outcomes
Primary Outcome Measures
Bleeding
Blood tinged sputum or hemoptysis reported by patient or patient caregiver to on call resident or at post operative appointment; blood clot or bleeding from tonsil bed observed objectively on physical examination.
Secondary Outcome Measures
Pain
Patient or patient caregiver report of pain at each post operative day using a validated Wong Baker FACES pain scale.
Days missed from normal activity
Patient or patient care giver reported number of days spent absent from normal activity as noted at post operative visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03437954
Brief Title
Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Official Title
Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research is being done because it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.
Detailed Description
Currently it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. Traditional standard of care is to recommend that patients be restricted to a soft diet post-operatively. However, the investigators believe that there may be benefit in allowing patients to eat a restriction-free diet. In this study, the investigators will compare the current standard of care verse a non-restricted diet. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tonsillitis, Sleep Disordered Breathing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard soft diet
Arm Type
Other
Arm Title
Non-restricted diet
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Diet modification
Intervention Description
Patients will be randomized to follow the standard post-tonsillectomy diet at our institution, which consists of soft foods for ten days, or will be in the non-restricted diet group following surgery.
Primary Outcome Measure Information:
Title
Bleeding
Description
Blood tinged sputum or hemoptysis reported by patient or patient caregiver to on call resident or at post operative appointment; blood clot or bleeding from tonsil bed observed objectively on physical examination.
Time Frame
From time of surgery through postoperative day 10.
Secondary Outcome Measure Information:
Title
Pain
Description
Patient or patient caregiver report of pain at each post operative day using a validated Wong Baker FACES pain scale.
Time Frame
From time of surgery through postoperative day 10.
Title
Days missed from normal activity
Description
Patient or patient care giver reported number of days spent absent from normal activity as noted at post operative visit.
Time Frame
From time of surgery through postoperative day 10.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Scriven, MD
Phone
202-444-8186
Email
kelly.a.scriven@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Earl Harley, MD
Phone
202-444-8186
Email
harleye@georgetown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earl Harley, MD
Organizational Affiliation
MedStar Georgetown University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Earl Harley, MD
Phone
202-444-8186
Email
harleye@georgetown.edu
12. IPD Sharing Statement
Learn more about this trial
Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
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