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

Tonsillitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02676583
• Other study ID #: OLFACT-TONSIL-01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 17, 2015
• Last updated: May 28, 2017
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: Clinica Olfact
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Procedure:
• Tonsillectomy
Closure or not closure of tonsil fossa

Locations

Country	Name	City	State
Brazil	Clinica Olfact	Londrina	PR

Sponsors (2)

Lead Sponsor	Collaborator
Marco Aurelio Fornazieri	Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain will be assessed using a questionnaire containing a Faces Pain Scale	on post-operative procedure (1 day after surgery)
Primary	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	Resumption of normal diet	wich day normal diet was recovered	at 7 days after surgery
Secondary	Healing characteristics	characteristics of edema, granuloma and uvula edema	at 7 days after surgery