Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients (IV APAP SF)
Pain, Postoperative
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring analgesic adjunct, acetaminophen, spine fusion surgery, opiate reduction, pain management after elective surgical operation
Eligibility Criteria
Inclusion Criteria:
Subjects 10-18 years who are status post anterior or posterior spine fusion surgery
Exclusion Criteria:
- All patients requiring mechanical ventilation post-operatively, continuous infusions of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
- Patients with hepatic dysfunction
- Patients with chronic opiate requirements
- Pregnant or lactating females
- Patients placed on opiates other than morphine or hydromorphone
- Patients with opiate or acetaminophen allergies
- Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
- Patients who receive intrathecal opiates
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Saline Placebo
Intravenous Acetaminophen
Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).