Efficacy of Acetaminophen in Posterior Fossa Surgery

• Status: Withdrawn
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's National Research Institute; Srijaya K. Reddy, MD, MBA
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

1. Any child undergoing posterior fossa surgery, including surgery for Chiari Malformation

2. The subject's American Society of Anesthesiologists physical status is 1, 2 or 3

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

4. Written informed consent from parent/guardian

Exclusion Criteria:

1. Subjects with known or suspected hypersensitivity reaction to acetaminophen

2. Presence or prior history of a known liver disease or coagulation disorder:

3. History of abnormal liver function

4. History of prior liver transplantation

5. Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)

6. History of prior acetaminophen overdose

7. Subjects with the need for mechanical ventilation prior to surgery or postoperatively

• unable to assess accurate pain scores in this context

8. The subject has a history or a family (parent or sibling) history of malignant hyperthermia

9. The subject had a recent opioid exposure (within 1 month of surgery)

10. The subject is obese (body mass index >30 kg/m2)

11. The subject is an American Society of Anesthesiologist physical status classification of 4 or greater

12. The subject is scheduled for a surgical sub-procedure

13. Subjects who have been previously enrolled in this protocol may not be enrolled again