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

Not Applicable

• Conditions: Chronic Tonsillitis; Sleep Disordered Breathing
• Interventions: Other: Diet modification

• Registration Number: NCT03437954
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard soft diet	Diet modification	-
Non-restricted diet	Diet modification	-

Primary Outcome Measures

Name	Time	Method
Bleeding	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

Name	Time	Method
Pain	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.
Days missed from normal activity	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.

Trial Locations

Locations (1)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States