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

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ClinicalTrials.gov Identifier: NCT01500109
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : April 1, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cleft Palate Drug: Oral acetaminophen Drug: Ofirmev® Drug: Opioid only

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Primary Completion Date : August 2014
Study Completion Date : August 2014

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U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   5 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chelan Nour, MD, Assistant Professor of Anesthesiology, Loma Linda University
ClinicalTrials.gov Identifier: NCT01500109     History of Changes
Other Study ID Numbers: 5110257
First Posted: December 26, 2011    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: November 28, 2017
Last Verified: October 2017

Keywords provided by Chelan Nour, MD, 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
Morphine
Analgesics, Opioid
Acetaminophen
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics