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Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy

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ClinicalTrials.gov Identifier: NCT03437954
Recruitment Status : Unknown
Verified March 2019 by Georgetown University.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Tonsillitis Sleep Disordered Breathing Other: Diet modification Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arms and Interventions
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Arm Intervention/treatment
Standard soft diet Other: Diet modification
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.
Non-restricted diet Other: Diet modification
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.


Outcome Measures
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Primary Outcome Measures :
  1. Bleeding [ Time Frame: From time of surgery through postoperative day 10. ]
    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 :
  1. Pain [ Time Frame: From time of surgery through postoperative day 10. ]
    Patient or patient caregiver report of pain at each post operative day using a validated Wong Baker FACES pain scale.

  2. Days missed from normal activity [ Time Frame: From time of surgery through postoperative day 10. ]
    Patient or patient care giver reported number of days spent absent from normal activity as noted at post operative visit.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437954


Contacts
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Contact: Kelly Scriven, MD 202-444-8186 kelly.a.scriven@gmail.com
Contact: Earl Harley, MD 202-444-8186 harleye@georgetown.edu

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Earl Harley, MD    202-444-8186    harleye@georgetown.edu   
Sponsors and Collaborators
Georgetown University
Investigators
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Study Director: Earl Harley, MD MedStar Georgetown University Hospital
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03437954    
Other Study ID Numbers: Georgetown_Univeristy_MC
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tonsillitis
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases