NCT02676583

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

October 17, 2015

Last Update Submit

May 28, 2017

Conditions

Tonsillitis

Keywords

paintonsillectomytonsillar fossasuturetonsil fossa closure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Resumption of normal diet

    at 7 days after surgery

  • Healing characteristics

    at 7 days after surgery

Study Arms (3)

Billateral tonsil fossa closure

ACTIVE COMPARATOR

tonsillectomy

Procedure: Tonsillectomy

No closure of tonsil fossa

ACTIVE COMPARATOR

tonsillectomy

Procedure: Tonsillectomy

Unilateral tonsil fossa closure

ACTIVE COMPARATOR

tonsillectomy

Procedure: Tonsillectomy

Interventions

TonsillectomyPROCEDURE

Closure or not closure of tonsil fossa

Billateral tonsil fossa closureNo closure of tonsil fossaUnilateral tonsil fossa closure

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • no cognitive-intellectual changes;
  • capacity to respond the questionnaire;
  • able to help in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Olfact

Londrina, Paraná, Brazil

Location

MeSH Terms

Conditions

TonsillitisPain

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Responsible MD

Study Record Dates

First Submitted

October 17, 2015

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

BR(1)