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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02676583
Enrollment
131
Registered
2016-02-08
Start date
2016-02-29
Completion date
2017-09-30
Last updated
2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillitis

Keywords

pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure

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.

Interventions

PROCEDURETonsillectomy

Closure or not closure of tonsil fossa

Sponsors

Universidade Estadual de Londrina
CollaboratorOTHER
Marco Aurelio Fornazieri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Painon post-operative procedure (1 day after surgery)Pain will be assessed using a questionnaire containing a Faces Pain Scale

Secondary

MeasureTime frameDescription
Resumption of normal dietat 7 days after surgerywich day normal diet was recovered
Healing characteristicsat 7 days after surgerycharacteristics of edema, granuloma and uvula edema

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026