TonsillectomyAMYAMBUNCT05915559
Outpatient Management of Tonsillectomy in Adults
A study testing Tonsillectomy and daily follow-up in people with Tonsillectomy and Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tonsillectomy, Pain, Ambulatory
- What is being tested?
- Tonsillectomy and daily follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indication for a tonsillectomy defined in the French recommendations
- Age between 18 and 60 yo
- Providing free and informed consent to participate
- Having a smartphone able to process MAELA application
- Affiliation to french social security
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.
- Conditions
- Tonsillectomy, Pain, Ambulatory
- Being tested
- Tonsillectomy, daily follow-up
- Keywords
- Tonsillectomy, Pain, ambulatory
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Tonsillectomy
daily follow-upOther
daily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy | Experimental | Not described Receives: Procedure: Tonsillectomy; Other: daily follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients EVA score less or equal at 3
EVA score is a pain scale from 0 to 10. 10 is the highest pain level.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jun 2023
- Primary completion17 May 2025
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915559
- Sponsor's protocol ID
- PI2022_843_0115
- Acronym
- AMYAMBU
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Management of Tonsillectomy in Adults
- ClinicalTrials.gov ID
- NCT05915559
- Acronym / sponsor ID
- AMYAMBU / PI2022_843_0115
- Conditions
- Tonsillectomy, Pain, Ambulatory
- Keywords
- Tonsillectomy, Pain, ambulatory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- 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.
Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy | Experimental | Procedure: Tonsillectomy, Other: daily follow-up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Indication for a tonsillectomy defined in the French recommendations
- Age between 18 and 60 yo
- Providing free and informed consent to participate
- Having a smartphone able to process MAELA application
- Affiliation to french social security
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TonsillectomyTonsillectomy | Procedure or surgery | Tonsillectomy |
| daily follow-updaily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain | Other | Tonsillectomy |
Primary outcome
Number of patients EVA score less or equal at 3
Time frame: day 1
EVA score is a pain scale from 0 to 10. 10 is the highest pain level.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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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 and daily follow-up in people with Tonsillectomy and Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients EVA score less or equal at 3 (time frame: day 1). 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 24 Aug 2025.