Clinical trial · Interventional
Efficacy of Acetaminophen in Posterior Fossa Surgery
Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): not enough patients meeting criteria
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arnold-Chiari Malformation | — | UNRESOLVED | — |
| Posterior Fossa Tumors | Posterior Fossa Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV acetaminophen | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IV acetaminophen
- description
- IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
- interventionNames
- Drug: IV acetaminophen
- type
- PLACEBO_COMPARATOR
- label
- normal saline
- description
- normal saline (placebo control) 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- Daily opioid consumption (mg/kg/24 hours using morphine equivalent)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDDe Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. doi: 10.1097/00006123-199603000-00008. PMID 8837797
- BACKGROUNDMorad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9. PMID 22156333
- BACKGROUNDBaley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64. PMID 24654353
- BACKGROUNDAlhashemi JA, Daghistani MF. Effect of intraoperative intravenous acetaminophen vs. intramuscular meperidine on pain and discharge time after paediatric dental restoration. Eur J Anaesthesiol. 2007 Feb;24(2):128-33. doi: 10.1017/S0265021506001232. Epub 2006 Aug 8. PMID 16895621
- BACKGROUNDAlhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. doi: 10.1093/bja/ael084. Epub 2006 Apr 13. PMID 16613928
- BACKGROUNDLahtinen P, Kokki H, Hendolin H, Hakala T, Hynynen M. Propacetamol as adjunctive treatment for postoperative pain after cardiac surgery. Anesth Analg. 2002 Oct;95(4):813-9, table of contents. doi: 10.1097/00000539-200210000-00005. PMID 12351250