Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children

Study Overview
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Brief Summary
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Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An inexpensive method and with few evidence in the literature on effectiveness in reducing pain is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators will compare the pain after tonsillectomy between closure or not the tonsil fossa. Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled from November 2015 to July 2016. The procedure will be performed by a single surgeon and similar postoperative medications will be prescribed. There will be two techniques: closure or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day of total improvement of the pain, day of beginning of normal food intake, presence of postoperative bleeding, complications and observations raised by the patient - will be applied.

Official Title
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Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study

Conditions
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Tonsillitis

Intervention / Treatment
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* Procedure: Tonsillectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no cognitive-intellectual changes; capacity to respond the questionnaire; able to help in the study Exclusion Criteria: conducting invasive procedure for less than two months; history of any infection during last month; continuous use of any medication; postoperative fever; non-standard medication prescribed for the postoperative time

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Billateral tonsil fossa closure<br>tonsillectomy | Procedure: Tonsillectomy<br>* Closure or not closure of tonsil fossa<br>|
| Active Comparator: No closure of tonsil fossa<br>tonsillectomy | Procedure: Tonsillectomy<br>* Closure or not closure of tonsil fossa<br>|
| Active Comparator: Unilateral tonsil fossa closure<br>tonsillectomy | Procedure: Tonsillectomy<br>* Closure or not closure of tonsil fossa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessed using a questionnaire containing a Faces Pain Scale | on post-operative procedure (1 day after surgery) | 
| Pain | Pain will be assessed using a questionnaire containing a Faces Pain Scale. It will be evaluated the presence of the Pain and the change between the two time points as well. | on post-operative procedure (7 days after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of normal diet | wich day normal diet was recovered | at 7 days after surgery | 
| Healing characteristics | characteristics of edema, granuloma and uvula edema | at 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure