IV Acetaminophen in Children Undergoing Palatoplasty

Nationwide Children's Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Cleft Palate

Treatments: Drug: Placebo; Drug: IV acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01760330

IRB12-00709

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

IV acetaminophen

Active Comparator group

Description:

IV acetaminophen administered q 4 hrs. for a total of 24 hrs.

Treatment:

Drug: IV acetaminophen

Placebo

Placebo Comparator group

Description:

Normal saline administered IV every 4 hrs. for a total of 24 hrs.

Treatment:

Drug: Placebo