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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Loma Linda University

Current Primary Outcome: Opioid (Fentanyl and Morphine) Consumption [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain Scores Using the Age-appropriate Pain Scale [ Time Frame: 24 hours ]

The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation


Original Secondary Outcome: Pain Scores Using the Age-appropriate Pain Scale [ Time Frame: 24 hours ]

The investigators will also be looking for the presense of pruritus, nausea, vomiting and/or sedation


Information By: Loma Linda University

Dates:
Date Received: December 19, 2011
Date Started: November 2011
Date Completion:
Last Updated: April 15, 2015
Last Verified: April 2015