Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
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).