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Postoperative Care After Tonsillectomy

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07792057
Acronym
ARAP
Enrollment
300
Registered
2026-08-28
Start date
2026-09-01
Completion date
2028-01-01
Last updated
2026-08-28

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

Conditions

Bleeding, Healing, Nutrition, Tonsillectomy

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.

Detailed description

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. The primary outcome will be the occurrence of secondary post-tonsillectomy hemorrhage, defined as any bleeding occurring 24 hours or more after surgery. Bleeding events will be recorded according to their clinical severity and management, including the need for medical evaluation, local intervention, hospital readmission, blood transfusion, or surgical hemostasis. Bleeding occurring within the first 24 postoperative hours will be recorded separately as a primary postoperative event but will not be included in the primary endpoint analysis. Secondary outcomes will include postoperative pain intensity assessed using age-appropriate validated pain scales on postoperative days 1, 3, 10, and 20; incidence of postoperative infection, nausea, and vomiting; time to resumption of a solid diet without significant discomfort; estimated caloric and protein intake during the first three postoperative days; need for surgical re-intervention; use of analgesic and anti-inflammatory medications; and patient or parent/legal guardian perception of oropharyngeal comfort. Adherence to both the nutritional supplementation and micronebulization protocols will also be assessed throughout the study period.

Interventions

DIETARY_SUPPLEMENTNutrition and Hydration

* 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.

Sponsors

Hospital Felicio Rocho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Secondary Post-Tonsillectomy Hemorrhage Occurring 24 Hours or More After SurgeryAfter 24 hours of surgery up to 30 days post-operativelySecondary 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.

Secondary

MeasureTime frameDescription
Mean Postoperative Pain Intensity Score Measured Using Age-Appropriate Validated Pain ScalesPostoperative days 1, 3, 10, and 20Postoperative pain intensity will be assessed using age-appropriate validated pain scales. The Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used for children aged 2-3 years, the Faces Pain Scale-Revised (FPS-R) for children aged 4-7 years, and the 11-point Numerical Rating Scale (NRS-11) for participants aged ≥8 years. Pain scores range from 0 to 10, with higher scores indicating greater pain intensity. The mean pain intensity score will be calculated for each participant across the predefined postoperative assessment days and compared between study groups
Number of Participants With Postoperative Infection Following TonsillectomyFrom 24 hours after surgery through postoperative day 20.Postoperative infection will be defined as a clinically diagnosed infection of the oropharyngeal surgical site requiring medical treatment, including antibiotic therapy, based on clinical assessment by the treating physician. The number of participants presenting with at least one postoperative infection will be recorded and compared between the intervention and control groups.
Number of Participants Requiring Surgical Re-Intervention for Postoperative HemorrhageFrom 24 hours after surgery through postoperative day 30The number of participants requiring surgical re-intervention for postoperative hemorrhage following tonsillectomy will be recorded. Surgical re-intervention will include operative procedures performed to achieve hemostasis as a consequence of post-tonsillectomy hemorrhage.

Countries

Brazil

Contacts

CONTACTAlan Rodrigues Paiva, MsC
alanrodriguesmd@gmail.com+5531996869586

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026