Cleft Palate
Conditions
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.
Interventions
DRUGIV acetaminophen
DRUGPlacebo
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 24 hrs. post-op. | Pain scores will be assessed. |
Secondary
| Measure | Time frame |
|---|---|
| Opioid consumption | 24 hrs. post-op |
Countries
United States
Outcome results
None listed