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

NCT07576985 | Enrolling By Invitation FDA Drug

• 1 other identifier: STUDY00000739
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tonsillectomy; Adenoidectomy

Keywords

acetaminophen; pain; pediatric; intravenous; per os; flacc; paed

Outcome Measures

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.

  * "Baseline" * "Perioperative/Periprocedural"

Secondary Outcomes (1)

• Agitation Assessment

  * "Baseline" * "Perioperative/Periprocedural"

Study Arms (2)

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

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

Acetaminophen per os; Intravenous Acetaminophen

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109-1997, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Pediatric Anesthesiologist

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 8, 2026
• Study Start: April 21, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)