Efficacy of Acetaminophen in Posterior Fossa Surgery

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Arnold-Chiari Malformation, Posterior Fossa Tumors

In brief

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.

Key facts

Study ID

NCT02532322

Run by

Children's National Research Institute

People needed

0

Starts

2015-11-01

Expected to finish

2018-10-01

Last updated by the study team

2021-04-08

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)
• History of prior acetaminophen overdose
• Subjects with the need for mechanical ventilation prior to surgery or postoperatively - unable to assess accurate pain scores in this context
• The subject has a history or a family (parent or sibling) history of malignant hyperthermia
• The subject had a recent opioid exposure (within 1 month of surgery)
• The subject is obese (body mass index >30 kg/m2)
• The subject is an American Society of Anesthesiologist physical status classification of 4 or greater
• The subject is scheduled for a surgical sub-procedure
• Subjects who have been previously enrolled in this protocol may not be enrolled again

Where it is running

• Children's National Health System — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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