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

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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate
• Intervention / Treatment: Drug: Ofirmev®; Drug: Oral acetaminophen; Drug: Opioid only

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ofirmev®; Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev® will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.	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.
Active Comparator: Oral acetaminophen; Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev® (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.	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.
Placebo Comparator: Opioid only; This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Chelan Nour, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Acetaminophen; cleft palate surgery; post-operative pain management
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 5110257