IV Acetaminophen in Children Undergoing Palatoplasty

Nationwide Children's Hospital

Overview

This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Cleft Palate

Interventions

IV acetaminophenDRUG

PlaceboDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * ASA physical status I or II * Presenting for repair of palatoplasty with Drs. Kirschner or Pearson Exclusion Criteria: * ASA physical status \> II * Underlying Syndrome * Significant co-morbid diseases (cardiac, pulmonary, neurological disease) * Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Pain

Pain scores will be assessed.

Time frame: 24 hrs. post-op.

Secondary Outcomes

Opioid consumption

Time frame: 24 hrs. post-op

Data from ClinicalTrials.gov

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