Tonsillar DisorderNCT07574476
Fasting Time and Post-tonsillectomy Pain
An observational study of Tonsillar Disorder, run by Brittany Willer at 1 site in United States.
Trial summary
This is a prospective, observational study to determine the association between preoperative fasting duration and post-tonsillectomy pain scores in the post-anesthesia care unit (PACU) among pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tonsillar Disorder
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to May 2029
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing tonsillectomy surgery
Who may be able to join
- undergoing elective tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement
Who cannot join
- non-elective or urgent procedures
- inpatient admission prior to surgery; patients with any missing required data
- patients with conditions requiring deviation from standard anesthetic management (as determined by the anesthesiologist)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Fasting Duration and Post-tonsillectomy Pain in Pediatric Patients
This is a prospective, observational study to determine the association between preoperative fasting duration and post-tonsillectomy pain scores in the post-anesthesia care unit (PACU) among pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The primary outcome is the post-tonsillectomy pain score, with the secondary outcomes as total postoperative opioid consumption, PACU length of stay, and hospital length of stay.
- Conditions
- Tonsillar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-tonsillectomy pain scores
Pain scores will be assessed in the post-anesthesia care unit (PACU) and on the inpatient floor (if admitted) every 15 minutes - 4 hours for the duration of their recovery until hospital discharge. The patient is asked to rate their pain on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable.
Measured: 2 - 24 hours post-op
Secondary outcomes (3)
Postoperative opioid consumption
The amount of opioid pain medication the patient received following their surgery until hospital discharge.
Measured: 2 - 24 hours post-op
PACU length of stay
Amount of time between admission to the post-anesthesia care unit (PACU) and discharge from the PACU.
Measured: 1 - 2 hours post-op
Hospital length of stay
Amount of time between admission to the pre-op unit prior to surgery until discharge from the hospital.
Measured: 4 - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start10 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brittany Willer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany Willer, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574476
- Sponsor's protocol ID
- STUDY00005766
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Duration and Post-tonsillectomy Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07574476
- Acronym / sponsor ID
- STUDY00005766
- Conditions
- Tonsillar Disorder
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brittany WillerUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 8 May 2026 (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.
This is a prospective, observational study to determine the association between preoperative fasting duration and post-tonsillectomy pain scores in the post-anesthesia care unit (PACU) among pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The primary outcome is the post-tonsillectomy pain score, with the secondary outcomes as total postoperative opioid consumption, PACU length of stay, and hospital length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing tonsillectomy surgery
Key inclusion criteria (1 listed)
- undergoing elective tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement
Key exclusion criteria (3 listed)
- non-elective or urgent procedures
- inpatient admission prior to surgery; patients with any missing required data
- patients with conditions requiring deviation from standard anesthetic management (as determined by the anesthesiologist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-tonsillectomy pain scores
Time frame: 2 - 24 hours post-op
Pain scores will be assessed in the post-anesthesia care unit (PACU) and on the inpatient floor (if admitted) every 15 minutes - 4 hours for the duration of their recovery until hospital discharge. The patient is asked to rate their pain on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable.
3 secondary outcomes
Postoperative opioid consumption
Time frame: 2 - 24 hours post-op
PACU length of stay
Time frame: 1 - 2 hours post-op
Hospital length of stay
Time frame: 4 - 24 hours
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 10 Sep 2026.
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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.
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?
An observational study of Tonsillar Disorder, run by Brittany Willer at 1 site in United States.
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 3 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. 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 United States. 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?
Post-tonsillectomy pain scores (time frame: 2 - 24 hours post-op). 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 10 Sep 2026.