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

Sleep Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03437954
• Other study ID #: Georgetown_Univeristy_MC
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Georgetown University
• Contact: Kelly Scriven, MD
• Phone: 202-444-8186
• Email: kelly.a.scriven[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Tonsillitis
• Sleep Apnea Syndromes
• Sleep Disordered Breathing
• Tonsillitis

Intervention

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.

Locations

Country	Name	City	State
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From time of surgery through postoperative day 10.
Secondary	Pain	Patient or patient caregiver report of pain at each post operative day using a validated Wong Baker FACES pain scale.	From time of surgery through postoperative day 10.
Secondary	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.	From time of surgery through postoperative day 10.