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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University
• Treatments: Acetaminophen; Analgesics, Opioid; Morphine

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