Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      An ideal drug as an opiate-sparing analgesic adjunct, acetaminophen, unlike some other drugs,
      is platelet function sparing, and thus particularly useful in the post-operative orthopedic
      patient population. In part because of its well established safety profile, as well as
      minimal drug interactions, acetaminophen is considered a cornerstone of a multimodal
      analgesic approach. Several studies have described the clinically significant beneficial
      effects of a multimodal drug approach to analgesia, citing improved pain control and a
      shorter recovery time. Reduced adverse events and improved pain control with multimodal
      analgesia drug approaches may result in shorter hospitalizations, improved recovery and
      function, and reduced health care costs. Opiate therapy, while effective analgesia, is
      associated with a variety of potential adverse side effects, including pruritus, nausea,
      emesis, ileus, respiratory depression, tolerance, addiction and sedation. These adverse
      effects may limit post-operative mobility, postpone return of bowel function, cause feeding
      intolerance, prolong hospitalization, and postpone post-operative recovery.

      While oral acetaminophen is useful as an opiate-sparing therapy, the oral route of drug
      administration may not be feasible in the early post-operative period. Enteral drug
      absorption in the initial post-operative period may be erratic, with negative impacts on
      therapeutic effect. Intravenous acetaminophen may a particularly useful analgesic in these
      circumstances. At present, there are no pediatric studies in the United States examining the
      efficacy of multiple- dose IV acetaminophen in the post-operative surgical population. This
      study will compare analgesic efficacy, nausea and pruritus scores, time to recovery, and
      length of hospital stay in two subject groups who are status post spine fusion surgery: those
      who receive schedule IV acetaminophen and opiate for 48 hours, and those who are treated with
      standard opiate therapy without IV acetaminophen.
    

Intervention name(s): Intravenous Acetaminophen; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesic adjunct; acetaminophen; spine fusion surgery; opiate reduction; pain management after elective surgical operation