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

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500109
• Other study ID #: 5110257
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: August 2014

Study information

• Verified date: June 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 5 Years

Eligibility

Inclusion Criteria:

• Children 5 months to five years of age

• ASA physical status I or II

• primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

• Repeat/revision cleft palate repair

• Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)

• Chronic pain medications

• Diagnosis of chronic pain syndrome

• Contraindications to morphine (renal impairment, allergy)

• Seizure disorders and/or taking anti-seizure medications

• Contraindications to oral midazolam (liver dysfunction, allergy)

• Allergy to local anesthetics

Related Conditions & MeSH terms

• Cleft Palate

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid (Fentanyl and Morphine) Consumption	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).	intraoperative period and first postoperative 24 hours