Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair - Full Text View

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:

Genetics Home Reference related topics: Baller-Gerold syndrome branchio-oculo-facial syndrome Crouzon syndrome

MedlinePlus related topics: Cleft Lip and Palate

Drug Information available for: Acetaminophen

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	October 2013 (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

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

Contacts

Contact: Joana Ratsiu, MD	909-558-8493	jratsiu@llu.edu
Contact: Patricia Moore	909-558-8493	pamoore@llu.edu

Locations

United States, California
Loma Linda University	Recruiting
Loma Linda, California, United States, 92354
Contact: Joana Ratsiu, MD 909-558-8493 jratsiu@llu.edu
Contact: Patricia Moore 909-558-8493 pamoore@llu.edu
Principal Investigator: Joana Ratsiu, MD

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator:

Joana Ratsiu, MD

Loma Linda University

More Information

No publications provided

Responsible Party:	Joana Ratsiu, 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:	April 16, 2013
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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 23, 2013