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Enrolling by invitation NCT07576985

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

Observational Tonsillectomy Adenoidectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Tonsillectomy, Adenoidectomy. Basic parameters: up to 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other No Intervention: Observational Cohort
    No Intervention: Observational Cohort

Primary outcome measures

  • Pain Assessment [Time frame: * "Baseline" * "Perioperative/Periprocedural"]
Secondary outcome measures (1)
  • Agitation Assessment [Time frame: * "Baseline" * "Perioperative/Periprocedural"]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • MetroHealth Medical Center — Cleveland

Identifiers

NCT: NCT07576985 · STUDY00000739

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗