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

Primary Purpose

Tonsillitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tonsillectomy
Sponsored by
Marco Aurelio Fornazieri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tonsillitis focused on measuring pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Olfact

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Billateral tonsil fossa closure

No closure of tonsil fossa

Unilateral tonsil fossa closure

Arm Description

tonsillectomy

tonsillectomy

tonsillectomy

Outcomes

Primary Outcome Measures

Pain
Pain will be assessed using a questionnaire containing a Faces Pain Scale
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.

Secondary Outcome Measures

Resumption of normal diet
wich day normal diet was recovered
Healing characteristics
characteristics of edema, granuloma and uvula edema

Full Information

First Posted
October 17, 2015
Last Updated
May 28, 2017
Sponsor
Marco Aurelio Fornazieri
Collaborators
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT02676583
Brief Title
Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children
Official Title
Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Aurelio Fornazieri
Collaborators
Universidade Estadual de Londrina

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Billateral tonsil fossa closure
Arm Type
Active Comparator
Arm Description
tonsillectomy
Arm Title
No closure of tonsil fossa
Arm Type
Active Comparator
Arm Description
tonsillectomy
Arm Title
Unilateral tonsil fossa closure
Arm Type
Active Comparator
Arm Description
tonsillectomy
Intervention Type
Procedure
Intervention Name(s)
Tonsillectomy
Intervention Description
Closure or not closure of tonsil fossa
Primary Outcome Measure Information:
Title
Pain
Description
Pain will be assessed using a questionnaire containing a Faces Pain Scale
Time Frame
on post-operative procedure (1 day after surgery)
Title
Pain
Description
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.
Time Frame
on post-operative procedure (7 days after surgery)
Secondary Outcome Measure Information:
Title
Resumption of normal diet
Description
wich day normal diet was recovered
Time Frame
at 7 days after surgery
Title
Healing characteristics
Description
characteristics of edema, granuloma and uvula edema
Time Frame
at 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinica Olfact
City
Londrina
State/Province
PR
Country
Brazil

12. IPD Sharing Statement

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

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