Postoperative Care After Tonsillectomy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorHospital Felicio Rocho
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Nutrition and HydrationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
After 24 hours of surgery up to 30 days post-operativelySecondary outcomes
1
Mean Postoperative Pain Intensity Score Measured Using Age-Appropriate Validated Pain Scales
Postoperative 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
Time frame
Postoperative days 1, 3, 10, and 202
Number of Participants With Postoperative Infection Following Tonsillectomy
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.
Time frame
From 24 hours after surgery through postoperative day 20.3
Number of Participants Requiring Surgical Re-Intervention for Postoperative Hemorrhage
The 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.
Time frame
From 24 hours after surgery through postoperative day 30Sponsors and contacts
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Source ClinicalTrials.gov
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