Who is sponsoring NCT01500109?

NCT01500109 is sponsored by Loma Linda University.

What condition does NCT01500109 study?

NCT01500109 studies Cleft Palate.

What drugs are being tested in NCT01500109?

Interventions: Oral acetaminophen, Ofirmev®, Opioid only.

What is the status of NCT01500109?

NCT01500109 is currently COMPLETED.

Last reviewed 2021-06-07 · How we verify

Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study

NCT01500109 NA COMPLETED Results posted

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.

Details

Lead sponsor	Loma Linda University
Phase	NA
Status	COMPLETED
Enrolment	45
Start date	2011-11
Completion	2014-08

Conditions

Cleft Palate

Interventions

Oral acetaminophen
Ofirmev®
Opioid only

Primary outcomes

Opioid (Fentanyl and Morphine) Consumption — intraoperative period and first postoperative 24 hours
The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).

Countries

United States