TonsillectomyPEACENCT07576985
Evaluating the Efficacy of Intravenous Acetaminophen (IV Tylenol) in Reducing Pain and Agitation in Pediatric Patients Undergoing Elective Tonsillectomy and/or Adenoidectomy
An observational study of Tonsillectomy and Adenoidectomy, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
MetroHealth's main campus administers IV Tylenol as part of its pain management protocol for elective tonsillectomy/adenoidectomy, whereas Parma campus does not. Comparing these practices provides an opportunity to evaluate the benefits of IV Tylenol for pain, agitation, and associated secondary outcomes in this… Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 1 Aug 2026
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing an elective tonsillectomy and adenoidectomy at MetroHealth Medical Center
Who may be able to join
- Subjects pediatric patients aged ≤7 years, observed by study team who will complete the scales
- Undergoing elective tonsillectomy and adenoidectomy.
Who cannot join
- Pre-existing neurological or developmental disorders impacting pain/agitation scores
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
MetroHealth Medical Center
Cleveland, Ohio, 44109-1997
About this study
MetroHealth's main campus administers IV Tylenol as part of its pain management protocol for elective tonsillectomy/adenoidectomy, whereas Parma campus does not. Comparing these practices provides an opportunity to evaluate the benefits of IV Tylenol for pain, agitation, and associated secondary outcomes in this population. The pain/agitation would be assessed with a validated tool PAED and FLACC
- Conditions
- Tonsillectomy, Adenoidectomy
- Being tested
- No Intervention: Observational Cohort
- Keywords
- acetaminophen, pain, pediatric, intravenous, per os, flacc, paed
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen per os | Patients who are administered Acetaminophen per os. Receives: Other: No Intervention: Observational Cohort | |
| Intravenous Acetaminophen | Patients who are administered Acetaminophen intravenously. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
Evaluate the impact of IV Acetaminophen on pain at emergence and in the Post-Anesthesia Care Unit (PACU) using a validated pediatric assessment tool, FLACC (Face, Legs, Activity, Cry, Consolable) Behavior Pain Assessment Tool.
Measured: * "Baseline" * "Perioperative/Periprocedural"
Secondary outcomes (1)
Agitation Assessment
Evaluate the impact of IV Tylenol on Agitation scores at emergence and in the Post-Anesthesia Care Unit (PACU) using a validated pediatric assessment tool, Pediatric Anesthesia Emergence Delirium (PAED) scale.
Measured: * "Baseline" * "Perioperative/Periprocedural"
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 start21 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Abdul Aleem, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576985
- Sponsor's protocol ID
- STUDY00000739
- Acronym
- PEACE
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Intravenous Acetaminophen (IV Tylenol) in Reducing Pain and Agitation in Pediatric Patients Undergoing Elective Tonsillectomy and/or Adenoidectomy
- ClinicalTrials.gov ID
- NCT07576985
- Acronym / sponsor ID
- PEACE / STUDY00000739
- Conditions
- Tonsillectomy, Adenoidectomy
- Keywords
- acetaminophen, pain, pediatric, intravenous, per os, flacc, paed
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (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.
MetroHealth's main campus administers IV Tylenol as part of its pain management protocol for elective tonsillectomy/adenoidectomy, whereas Parma campus does not. Comparing these practices provides an opportunity to evaluate the benefits of IV Tylenol for pain, agitation, and associated secondary outcomes in this population. The pain/agitation would be assessed with a validated tool PAED and FLACC
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen per os | – | Other: No Intervention: Observational CohortPatients who are administered Acetaminophen per os. |
| Intravenous Acetaminophen | – | Other: No Intervention: Observational CohortPatients who are administered Acetaminophen intravenously. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing an elective tonsillectomy and adenoidectomy at MetroHealth Medical Center
Key inclusion criteria (2 listed)
- Subjects pediatric patients aged ≤7 years, observed by study team who will complete the scales
- Undergoing elective tonsillectomy and adenoidectomy.
Key exclusion criteria (1 listed)
- Pre-existing neurological or developmental disorders impacting pain/agitation scores
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | Acetaminophen per os, Intravenous Acetaminophen |
Primary outcome
Pain Assessment
Time frame: * "Baseline" * "Perioperative/Periprocedural"
Evaluate the impact of IV Acetaminophen on pain at emergence and in the Post-Anesthesia Care Unit (PACU) using a validated pediatric assessment tool, FLACC (Face, Legs, Activity, Cry, Consolable) Behavior Pain Assessment Tool.
1 secondary outcome
Agitation Assessment
Time frame: * "Baseline" * "Perioperative/Periprocedural"
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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 Tonsillectomy and Adenoidectomy, run by MetroHealth Medical Center 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 2 inclusion and 1 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 8 May 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?
Pain Assessment (time frame: * "Baseline" * "Perioperative/Periprocedural"). 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 8 May 2026.