Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intravenous Acetaminophen; Placebo
Intervention description: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.; Saline placebo will be given 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).
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: analgesic adjunct; acetaminophen; spine fusion surgery; opiate reduction; pain management after elective surgical operation

Summary:

      This is a prospective, randomized, double-blinded, placebo controlled trial Potential
      subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal
      guardians will be approached about study participation at the Anesthesia outpatient
      pre-visit. Attending Anesthesiologist will receive e-mail notification about potential
      subject participation the day before the scheduled surgery. Study lab (hepatic function
      panel) will be collected as soon as possible after anesthesia induction by anesthesia.
      Results will be reviewed by study team member and study drug will be ordered by study team if
      patient does not meet exclusion criteria. Study drug (IV acetaminophen or placebo) will be
      administered at the time of skin closure by anesthesia on completion of the surgical
      procedure (after randomization). Study drug will be administered every 6 hours for 2 days.
      Subjects will continue to receive standard of care with patient controlled analgesia (PCA)
      opiate therapy (morphine or hydromorphone) for analgesia as per the Pain Management Service.
      Pain scores, opiate (morphine equivalent) administered, requirements for treatment of opiate
      related side effects (treatment for nausea and itching), and certain post-operative
      characteristics will be measured for up to 4 days post-operatively (time to mobilization,
      time to diet advancement, time to discharge).
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects 10-18 years who are status post anterior or posterior spine fusion surgery

        Exclusion Criteria:

          1. All patients requiring mechanical ventilation post-operatively, continuous infusions
             of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)

          2. Patients with hepatic dysfunction

          3. Patients with chronic opiate requirements

          4. Pregnant or lactating females

          5. Patients placed on opiates other than morphine or hydromorphone

          6. Patients with opiate or acetaminophen allergies

          7. Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)

          8. Patients who receive intrathecal opiates