IV Acetaminophen in Children Undergoing Palatoplasty

NCT01760330 | Withdrawn Phase 2

• 1 other identifier: IRB12-00709
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain scores will be assessed.

  24 hrs. post-op.

Secondary Outcomes (1)

• Opioid consumption

  24 hrs. post-op

Study Arms (2)

IV acetaminophen

ACTIVE COMPARATOR

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

Drug: IV acetaminophen

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IV acetaminophen DRUG

Also known as: Ofirmev

IV acetaminophen

Placebo DRUG

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II
• Presenting for repair of palatoplasty with Drs. Kirschner or Pearson

You may not qualify if:

• ASA physical status \> II
• Underlying Syndrome
• Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Cleft Palate

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 4, 2013
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)