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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03437954
Enrollment
86
Registered
2018-02-19
Start date
2017-12-15
Completion date
2019-12-31
Last updated
2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Tonsillitis, Sleep Disordered Breathing

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.

Interventions

OTHERDiet 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.

Sponsors

Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
BleedingFrom 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

MeasureTime frameDescription
PainFrom 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 activityFrom 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.

Countries

United States

Contacts

Primary ContactKelly Scriven, MD
kelly.a.scriven@gmail.com202-444-8186
Backup ContactEarl Harley, MD
harleye@georgetown.edu202-444-8186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026