Tonsillar DisorderDACAANCT04853173
Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults
A study testing Assess pain management modalities in adult outpatient tonsillectomy surgery in people with Tonsillar Disorder, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillar Disorder
- What is being tested?
- Assess pain management modalities in adult outpatient tonsillectomy surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2021to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- programmed Tonsillectomy surgery
Who cannot join
- Congenital or acquired hemostasis disorder
- Indication of uvulo-bike-pharyngo-plasty
- Contraindication to the use of one of the protocol molecules including pregnancy
- Allergy to analgesic treatments used in the study
- Ongoing analgesic treatment that cannot be interrupted
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Laurent TAVERNIER, 0381669360, ltavernier@chu-besancon.fr
About this study
Official title: Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study
No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.
- Conditions
- Tonsillar Disorder
- Being tested
- Assess pain management modalities in adult outpatient tonsillectomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess pain management modalities in adult outpatient tonsillectomy surgeryOther
use a post-operative analgesia protocol suitable for outpatient surgery. Namely a protocol of analgesia based on the taking of drugs per bone (by mouth) and not intravenous. Pain evaluation.
| Study group | Role | What they receive |
|---|---|---|
| ambulatory protocol after adult tonsillectomy | Experimental | prescription of analgesics for outpatient procedure with hospital surveillance Receives: Other: Assess pain management modalities in adult outpatient tonsillectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management.
Pain measured by self-assessment by Analog Visual Scale (0-10). If score is under 4 = efficacity of ansthesia protocol
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start9 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillar DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Model description
- Assess pain management modalities in adult outpatient tonsillectomy surgery
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853173
- Sponsor's protocol ID
- 2020/542
- Acronym
- DACAA
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study
- ClinicalTrials.gov ID
- NCT04853173
- Acronym / sponsor ID
- DACAA / 2020/542
- Conditions
- Tonsillar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Apr 2021 (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.
No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assess pain management modalities in adult outpatient tonsillectomy surgery
| Arm | Type | Receives |
|---|---|---|
| ambulatory protocol after adult tonsillectomy | Experimental | Other: Assess pain management modalities in adult outpatient tonsillectomy surgeryprescription of analgesics for outpatient procedure with hospital surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- programmed Tonsillectomy surgery
Key exclusion criteria (5 listed)
- Congenital or acquired hemostasis disorder
- Indication of uvulo-bike-pharyngo-plasty
- Contraindication to the use of one of the protocol molecules including pregnancy
- Allergy to analgesic treatments used in the study
- Ongoing analgesic treatment that cannot be interrupted
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 |
|---|---|---|
| Assess pain management modalities in adult outpatient tonsillectomy surgeryuse a post-operative analgesia protocol suitable for outpatient surgery. Namely a protocol of analgesia based on the taking of drugs per bone (by mouth) and not intravenous. Pain evaluation. | Other | ambulatory protocol after adult tonsillectomy |
Primary outcome
Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management.
Time frame: 14 days
Pain measured by self-assessment by Analog Visual Scale (0-10). If score is under 4 = efficacity of ansthesia protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assess pain management modalities in adult outpatient tonsillectomy surgery in people with Tonsillar Disorder, run by Centre Hospitalier Universitaire de Besancon 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 1 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 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent TAVERNIER, PU-PH (0381669360, ltavernier@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management. (time frame: 14 days). 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 19 Sep 2024.