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Enrolling by invitationNCT07576985PEACEUpdated May 8, 2026

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 in Tonsillectomy and Adenoidectomy, sponsored by MetroHealth Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged Up to 8 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by MetroHealth Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
Up to 8 Years
Sex
All
01

Study 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 population. The pain/agitation would be assessed with a validated tool PAED and FLACC

02

Conditions studied

  • Tonsillectomy
  • Adenoidectomy

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Keywords

  • acetaminophen
  • pain
  • pediatric
  • intravenous
  • per os
  • flacc
  • paed
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 1,252 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

MetroHealth Medical Center is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients undergoing an elective tonsillectomy and adenoidectomy at MetroHealth Medical Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects pediatric patients aged ≤7 years, observed by study team who will complete the scales
  • Undergoing elective tonsillectomy and adenoidectomy.

Exclusion criteria

Exclusion Criteria:

  • Pre-existing neurological or developmental disorders impacting pain/agitation scores
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acetaminophen per os

    Patients who are administered Acetaminophen per os.

    Other: No Intervention: Observational Cohort

  • Intravenous Acetaminophen

    Patients who are administered Acetaminophen intravenously.

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No Intervention: Observational Cohort

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: * "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.

    Time frame: * "Baseline" * "Perioperative/Periprocedural"

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07576985
Responsible party
Bushra Abdul Aleem (Principal Investigator - Pediatric Anesthesiologist, MetroHealth Medical Center) — Principal investigator
First posted
May 8, 2026
Start date
Apr 21, 2025
Primary completion
May 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
May 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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