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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tonsillitis
• Intervention / Treatment: Procedure: Tonsillectomy

• Study Type: Interventional
• Enrollment (Anticipated): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PR
    • Londrina, PR, Brazil
      • Clinica Olfact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Billateral tonsil fossa closure; tonsillectomy	Procedure: Tonsillectomy; Closure or not closure of tonsil fossa
Active Comparator: No closure of tonsil fossa; tonsillectomy	Procedure: Tonsillectomy; Closure or not closure of tonsil fossa
Active Comparator: Unilateral tonsil fossa closure; tonsillectomy	Procedure: Tonsillectomy; Closure or not closure of tonsil fossa

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marco Aurelio Fornazieri
• Collaborators: Universidade Estadual de Londrina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: October 17, 2015
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 28, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pain; suture; tonsillectomy; tonsillar fossa; tonsil fossa closure
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis
• Other Study ID Numbers: OLFACT-TONSIL-01