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| Name | Class |
|---|---|
| Universidade Estadual de Londrina | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Billateral tonsil fossa closure | Active Comparator | tonsillectomy |
|
| No closure of tonsil fossa | Active Comparator | tonsillectomy |
|
| Unilateral tonsil fossa closure | Active Comparator | tonsillectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonsillectomy | Procedure | Closure or not closure of tonsil fossa |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Olfact | Londrina | Paraná | Brazil |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| at 7 days after surgery |
| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |