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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chelan Nour, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01500109
First received: December 19, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cleft Palate
Drug: Oral acetaminophen
Drug: Ofirmev®
Drug: Opioid only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Opioid (Fentanyl and Morphine) consumption [ Time Frame: intraoperative period and first postoperative 24 hours ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Pain scores using the age-appropriate pain scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation


Estimated Enrollment: 48
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500109

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Chelan Nour, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Chelan Nour, MD, Assistant Professor of Anesthesiology, Loma Linda University
ClinicalTrials.gov Identifier: NCT01500109     History of Changes
Other Study ID Numbers: 5110257
Study First Received: December 19, 2011
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
cleft palate surgery
post-operative pain management
Acetaminophen

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Acetaminophen
Analgesics, Opioid
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 21, 2014