drugset / Trial / NCT01500109

Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair

NCT01500109 ↗

Completed 45 enrolled Loma Linda University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.

Timeline

Start
2011-11
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 12.5 mg/kg Oral
Comparator Acetaminophen Small molecule 15 mg/kg Oral
Comparator Fentanyl Other / unclassified 0.5 ug/kg —
Comparator Fentanyl Other / unclassified 1 ug/kg —
Comparator Morphine Other / unclassified 0.05 mg/kg Intravenous

Indications