Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
Completed · Not applicable · Has a placebo group
Conditions studied: Cleft Palate
In brief
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.
Key facts
- Study ID
- NCT01500109
- Run by
- Loma Linda University
- People needed
- 45
- Starts
- 2011-11-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2021-06-09
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.?
You may not qualify if…
- 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
Where it is running
- Loma Linda University — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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