Evaluating the Efficacy of Intravenous Acetaminophen (IV Tylenol) in Reducing Pain and Agitation in Pediatric Patients Undergoing Elective Tonsillectomy and/or Adenoidectomy

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

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Key information

Conditions

Tonsillectomy Adenoidectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109-1997, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

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.

Secondary outcomes

Agitation Assessment

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

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.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Acronym: PEACE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 8, 2026
Registry last updated: May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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