Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 3/28/2019 |
| Start Date: | November 2011 |
| End Date: | August 2014 |
Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study
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.
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.
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
We found this trial at
1
site
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
Click here to add this to my saved trials
