NCT02676583

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: Marco Aurelio Fornazieri · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tonsillitis

Interventions

Type	Name	Description
PROCEDURE	Tonsillectomy	Closure or not closure of tonsil fossa

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2016-02-08
• Last updated: 2017-05-31

Locations

1 site across 1 country: Brazil