Efficacy of Acetaminophen in Posterior Fossa Surgery (NCT02532322) | Clinical Trial Compass
WithdrawnPhase 2
Efficacy of Acetaminophen in Posterior Fossa Surgery
Stopped: not enough patients meeting criteria
United States0Started 2015-11
Plain-language summary
Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children. However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in children undergoing posterior fossa surgery. In this prospective, randomized controlled trial, the investigators aim to determine whether the addition of IV acetaminophen for 24 hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical procedures of the posterior fossa compared with conventional therapy.
Who can participate
Age range2 Years – 12 Years
SexALL
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Inclusion criteria
✓. Any child undergoing posterior fossa surgery, including surgery for Chiari Malformation
✓. The subject's American Society of Anesthesiologists physical status is 1, 2 or 3
✓. Males and females 2 to 12 years old (minorities will be included) - recommended dosing of IV acetaminophen in children is approved for children 2 to 12 years of age
✓. Written informed consent from parent/guardian
Exclusion criteria
✕. Subjects with known or suspected hypersensitivity reaction to acetaminophen
✕. Presence or prior history of a known liver disease or coagulation disorder:
✕. History of abnormal liver function
✕. History of prior liver transplantation
✕. Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
✕
What they're measuring
1
Daily opioid consumption (mg/kg/24 hours using morphine equivalent)