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

Information source: Loma Linda University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cleft Palate

Intervention: Oral acetaminophen (Drug); Ofirmev® (Drug); Opioid only (Drug)

Phase: N/A

Status: Completed

Sponsored by: Loma Linda University

Official(s) and/or principal investigator(s):
Chelan Nour, MD, Principal Investigator, Affiliation: Loma Linda University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Opioid (Fentanyl and Morphine) Consumption

Secondary outcome: Pain Scores Using the Age-appropriate Pain Scale

Eligibility

Minimum age: 5 Months. Maximum age: 5 Years. Gender(s): Both.

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

Locations and Contacts

Loma Linda University, Loma Linda, California 92354, United States
Additional Information

Starting date: November 2011
Last updated: April 15, 2015

Page last updated: August 23, 2015

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