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

Not Applicable

• Conditions: Tonsillitis
• Interventions: Procedure: Tonsillectomy

• Registration Number: NCT02676583
• Lead Sponsor: Marco Aurelio Fornazieri

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-17
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-28
• Last Update Posted: 2017-05-31
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Billateral tonsil fossa closure	Tonsillectomy	tonsillectomy
Unilateral tonsil fossa closure	Tonsillectomy	tonsillectomy
No closure of tonsil fossa	Tonsillectomy	tonsillectomy

Primary Outcome Measures

Name	Time	Method
Pain	on post-operative procedure (7 days after surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Healing characteristics	at 7 days after surgery	characteristics of edema, granuloma and uvula edema
Resumption of normal diet	at 7 days after surgery	wich day normal diet was recovered

Trial Locations

Locations (1)

Clinica Olfact; 🇧🇷 Londrina, PR, Brazil