TonsillitisNCT02676583
Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children
A study testing Tonsillectomy in people with Tonsillitis, run by Marco Aurelio Fornazieri at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no cognitive-intellectual changes;
- capacity to respond the questionnaire;
- able to help in the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study
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
- Being tested
- Tonsillectomy
- Keywords
- pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure
- Medical subject headings
- Tonsillitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Closure or not closure of tonsil fossa
| Study group | Role | What they receive |
|---|---|---|
| Billateral tonsil fossa closure | Active comparator | tonsillectomy Receives: Procedure: Tonsillectomy |
| No closure of tonsil fossa | Active comparator | tonsillectomy Receives: Procedure: Tonsillectomy |
| Unilateral tonsil fossa closure | Active comparator | tonsillectomy Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be assessed using a questionnaire containing a Faces Pain Scale
Measured: 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.
Measured: on post-operative procedure (7 days after surgery)
Secondary outcomes (2)
Resumption of normal diet
wich day normal diet was recovered
Measured: at 7 days after surgery
Healing characteristics
characteristics of edema, granuloma and uvula edema
Measured: at 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Aurelio Fornazieri
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Sponsor-investigator, Marco Aurelio Fornazieri, Clinica Olfact
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676583
- Sponsor's protocol ID
- OLFACT-TONSIL-01
- Status last verified
- May 2017
- First submitted
- 17 Oct 2015
- Last updated
- 31 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT02676583
- Acronym / sponsor ID
- OLFACT-TONSIL-01
- Conditions
- Tonsillitis
- Keywords
- pain, tonsillectomy, tonsillar fossa, suture, tonsil fossa closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Marco Aurelio FornazieriUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Billateral tonsil fossa closure | Active comparator | Procedure: Tonsillectomytonsillectomy |
| No closure of tonsil fossa | Active comparator | Procedure: Tonsillectomytonsillectomy |
| Unilateral tonsil fossa closure | Active comparator | Procedure: Tonsillectomytonsillectomy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- no cognitive-intellectual changes;
- capacity to respond the questionnaire;
- able to help in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillectomyClosure or not closure of tonsil fossa | Procedure or surgery | Billateral tonsil fossa closure, No closure of tonsil fossa, Unilateral tonsil fossa closure |
Primary outcome
Pain
Time frame: on post-operative procedure (1 day after surgery)
Pain will be assessed using a questionnaire containing a Faces Pain Scale
Pain
Time frame: on post-operative procedure (7 days after surgery)
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.
2 secondary outcomes
Resumption of normal diet
Time frame: at 7 days after surgery
Healing characteristics
Time frame: at 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Related trials for Tonsillitis
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Peritonsillar Abscess, Peritonsillar Cellulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy in people with Tonsillitis, run by Marco Aurelio Fornazieri at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: on post-operative procedure (1 day after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.