The Impact of Postoperative Care After Tonsillectomy: A Randomized Clinical Trial

The primary objective of this study is to evaluate the effect of an individualized protein supplementation strategy combined with oropharyngeal mucosal humidification using a micronebulizer on the occurrence of secondary post-tonsillectomy hemorrhage, defined as bleeding occurring 24 hours or more after surgery, in patients of all ages undergoing tonsillectomy at Hospital Felício Rocho. Secondary objectives are to evaluate postoperative pain intensity using age-appropriate validated pain scales; assess the incidence of other postoperative complications, including infection, nausea, and vomiting; compare the time to resumption of a solid diet without significant discomfort; evaluate caloric and protein intake during the initial postoperative period; assess patients' perception of oropharyngeal mucosal comfort using validated questionnaires or standardized clinical assessment; and evaluate adherence to the protein supplementation and micronebulization protocols.

This study will be conducted as a prospective, randomized, controlled clinical trial with two parallel groups, consisting of an intervention group and a control group, at Hospital Felício Rocho in Belo Horizonte, Minas Gerais, Brazil. The study population will comprise children and adults undergoing elective tonsillectomy who meet the eligibility criteria. Inclusion criteria will include an age of ≥2 years and provision of written informed consent by the patient or legal guardian, as applicable, with informed assent obtained from participants when appropriate. Exclusion criteria will include hematological disorders, contraindications to oral or enteral intake, active neoplasia, known hypersensitivity to any component of the nutritional supplementation or micronebulization solution, and anatomical abnormalities of the oropharynx that may interfere with the study intervention or outcome assessment. The sample size was calculated based on the expected rate of postoperative complications, assuming 80% statistical power and a two-sided significance level of 5%, with an additional 10% to account for potential losses to follow-up, resulting in a target sample of 146 participants per group. Eligible participants will be randomized in a 1:1 ratio using computer-generated block randomization. The study will follow a single-blind design, with outcome assessors blinded to treatment allocation.

Participants assigned to the intervention group will receive an individualized protein supplementation strategy initiated after completion of the prescribed postoperative fasting period. The nutritional intervention will target a daily protein intake of 1.3 g/kg/day for children and 2.0 g/kg/day for adults, administered through oral or enteral routes according to the patient's clinical condition and tolerance. Nutritional intake and adherence will be monitored daily by the nutrition team. In addition, participants in the intervention group will undergo scheduled oropharyngeal mucosal humidification through micronebulization with 10 mL of 0.9% sodium chloride solution every 8 hours for 20 postoperative days, using a standardized micronebulizer.

Participants in the control group will receive the institution's standard postoperative diet and routine nutritional care, without additional protein supplementation beyond usual clinical recommendations. Oropharyngeal humidification will be provided according to standard institutional care, without routine micronebulization, except when clinically indicated and prescribed by the treating medical team.

Data will be collected from medical records, patient or parent/legal guardian interviews, and direct clinical assessments. Baseline variables will include demographic characteristics, age, sex, preoperative weight, and height. Surgical variables will include operative duration, surgical technique, intraoperative complications, and other relevant perioperative characteristics.