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

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Cleft Palate
Interventions
DRUG

Oral acetaminophen

Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.

DRUG

Ofirmev®

Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.

DRUG

Opioid only

Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.

Trial Locations (1)

92354

Loma Linda University, Loma Linda

All Listed Sponsors
lead

Loma Linda University

OTHER

NCT01500109 - Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair | Biotech Hunter | Biotech Hunter