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

Marco Aurelio Fornazieri

Status: Unknown

Conditions: Tonsillitis

Treatments: Procedure: Tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02676583

OLFACT-TONSIL-01

Details and patient eligibility

About

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.

Enrollment: 131 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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131 participants in 3 patient groups

Billateral tonsil fossa closure

Active Comparator group

Description:

tonsillectomy

Treatment:

Procedure: Tonsillectomy

No closure of tonsil fossa

Active Comparator group

Description:

tonsillectomy

Treatment:

Procedure: Tonsillectomy

Unilateral tonsil fossa closure

Active Comparator group

Description:

tonsillectomy

Treatment:

Procedure: Tonsillectomy