Status:
COMPLETED
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
Lead Sponsor:
Loma Linda University
Conditions:
Cleft Palate
Eligibility:
All Genders
5-5 years
Phase:
NA
Brief 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. A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01500109
Start Date
November 1 2011
End Date
August 1 2014
Last Update
June 9 2021
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92354