Postoperative Care After Tonsillectomy

NCT07792057 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 96035626.2.0000.5125
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Tonsillectomy is one of the most common surgical procedures performed on both pediatric and adult patients; it is frequently associated with significant postoperative pain, difficulty swallowing, and the risk of complications such as bleeding and infection. The recovery period requires care aimed at minimizing discomfort, promoting healing, and preventing adverse events. Metabolic demands increase postoperatively due to surgical stress and the tissue repair process. Adequate nutrition, with a focus on protein intake, is fundamental for the synthesis of new proteins, the repair of injured tissues, and the maintenance of immune function-all essential for rapid, effective recovery and the prevention of complications. Insufficient protein intake can compromise surgical wound healing and the immune response. Additionally, the integrity and hydration of the oropharyngeal mucosa are crucial following a tonsillectomy. Surgical trauma and exposure to ambient air (especially after anesthesia and intubation) can lead to mucosal dryness, pain, discomfort, and scab formation, potentially hindering healing and increasing the risk of secondary infections. Micronebulization with saline solutions emerges as a potential intervention to hydrate the mucosa, alleviate discomfort, and promote the healing process. Despite the recognized importance of nutrition and local humidification, evidence regarding the combined impact of protein supplementation strategies and the use of micronebulizers on the recovery of patients undergoing tonsillectomy-specifically within a randomized clinical trial-requires further investigation. This study aims to contribute to the evidence base by evaluating the efficacy of these combined interventions on relevant clinical outcomes.

Conditions

Tonsillectomy; Bleeding; Nutrition; Healing

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Secondary Post-Tonsillectomy Hemorrhage Occurring 24 Hours or More After Surgery

  Secondary post-tonsillectomy hemorrhage will be defined as any episode of bleeding occurring 24 hours or more after tonsillectomy. The number of participants experiencing at least one bleeding episode will be recorded and compared between the intervention and control groups. Bleeding events will be documented according to clinical severity and management, including the need for medical evaluation, local intervention, hospital readmission, blood transfusion, or surgical hemostasis.

  After 24 hours of surgery up to 30 days post-operatively

Secondary Outcomes (3)

• Mean Postoperative Pain Intensity Score Measured Using Age-Appropriate Validated Pain Scales

  Postoperative days 1, 3, 10, and 20

• Number of Participants With Postoperative Infection Following Tonsillectomy

  From 24 hours after surgery through postoperative day 20.

• Number of Participants Requiring Surgical Re-Intervention for Postoperative Hemorrhage

  From 24 hours after surgery through postoperative day 30

Study Arms (2)

Control

NO INTERVENTION

Standard guidelines

Nutrition and Hydration

EXPERIMENTAL

Nutritiona and Hydration

Dietary Supplement: Nutrition and Hydration

Interventions

Nutrition and Hydration DIETARY_SUPPLEMENT

* Optimized Protein Nutrition: Following the fasting period and as tolerated, patients will receive a diet with individualized protein supplementation, aiming to achieve a protein intake of \[1.3 g/kg/day for children and 2 g/kg/day for adults\]. Supplementation may be administered orally (liquid or powdered nutritional supplements, fortified foods) or, if necessary, via enteral tube. Protein intake will be monitored daily by the nutrition team. * Mucosal Humidification: Micro-nebulization sessions using 10 mL of 0.9% normal saline will be performed every 8 hours with a standard micro-nebulizer for a period of 20 days. Patients or their caregivers will be instructed on the correct technique.

Also known as: Hydration

Nutrition and Hydration

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective tonsillectomy.
• Age ≥ 2 years
• Signature of the Informed Consent Form (ICF) by participants aged 18 years or older, or by parents/legal guardians for those under 18, accompanied by the signature of the Informed Assent Form (IAF) by the minor participant, respecting their capacity for understanding.

You may not qualify if:

• Hematologic disorders: Patients with coagulopathies or severe blood abnormalities.
• Oral/enteral route: Patients with a contraindication to oral or enteral intake.
• Neoplasms: Patients with active neoplasia.
• Hypersensitivity: Patients with known allergies to dietary components or nebulization solutions.
• Anatomic anomalies: Presence of oropharyngeal abnormalities that could compromise healing regardless of the intervention.
• Lack of consent: Formal refusal to participate in the study.

Sponsors & Collaborators

• Hospital Felicio Rocho: lead

Study Sites (1)

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Central Study Contacts

Alan Rodrigues Paiva, MsC

CONTACT

+5531996869586; alanrodriguesmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor; Principal Investigator and Assistant Professor of Medicine; Master's Degree in Surgery - UFMG; Clinical Assistant Professor of Medicine - UFMG.

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)