Clinical Trial: Efficacy of Acetaminophen in Posterior Fossa Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery

Brief Summary: 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.

Detailed Summary:

The primary goal of this study is to compare the efficacy of IV acetaminophen to placebo in pediatric patients undergoing posterior fossa surgery, with the primary outcome measure being postoperative opioid requirements (morphine equivalent mg/kg). This will be a prospective, randomized, double blind control trial. The patient, research team, surgeon, and anesthesiologist will all be blinded to the patient's treatment group. Patients will receive either IV acetaminophen or equal volume normal saline (placebo) in the perioperative period.

The interventional component of this study involves the intraoperative and postoperative administration of IV acetaminophen. Intraoperative and postoperative data pertaining to adverse events would be collected for safety monitoring purposes.

Enrolled subjects will be randomized to receive either IV acetaminophen or equal volume saline placebo during surgery and for 24 hours postoperatively. According to a computer-generated table of random number assignments, each patient will be randomly assigned to receive one of the following two treatment groups:

Treatment group 1:

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). This dosing regimen was chosen based on pharmacokinetic data and recommended dosing guidelines for IV acetaminophen in children 2 to 12 years of age.

Treatment group 2:

Equal volume of normal saline (placebo control) at the same dose and frequency as treatment group 1.

Sponsor: Srijaya K. Reddy, MD, MBA

Current Primary Outcome: Daily opioid consumption (mg/kg/24 hours using morphine equivalent) [ Time Frame: 72 hours postoperatively ]

Equianalgesic conversion of opioid consumption to morphine equivalent will be used

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Average daily pain scores using Wong-Baker Faces or Numeric Pain Scale [ Time Frame: 72 hours postoperatively ]
    Scores range from 0 [no pain] to 10 [worst possible pain]
  • Average daily sedation scores using University of Michigan Sedation Scale [ Time Frame: 72 hours postoperatively ]
    Score range from 0 [completely awake] to 4 [asleep but not responsive to any stimuli]
  • Incidence of opioid-induced side effects [ Time Frame: 72 hours postoperatively ]
    1. Incidence of postoperative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics (i.e. ondansetron or promethazine given as needed)
    2. Incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic (i.e. diphenhydramine or hydroxyzine given as needed for pruritus)

Original Secondary Outcome: Same as current

Information By: Children's Research Institute

Date Received: August 21, 2015
Date Started: November 2015
Date Completion: October 2018
Last Updated: March 13, 2017
Last Verified: March 2017