Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?

Overview

The purpose of this study is to determine whether IV acetaminophen can decrease the need for subsequent opioid administration in the acute management of sickle cell crisis pain in the pediatric emergency room.

Full Title of Study: “Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 20, 2020

Detailed Description

This is a single-center, prospective, randomized, double-blinded, controlled study in an academic urban pediatric emergency department of children with sickle cell disease presenting with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10 or higher on the Wong-Baker modified FACES pain scale. In order to detect a difference of 0.2 mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we calculated a sample size of 33 patients in each group. All patients will receive IV ketorolac and IV morphine. Patients will be randomized to receive IV acetaminophen or IV saline (volume-equivalent). Pain scores will be obtained at baseline, and again at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after medication administration. Cumulative morphine dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed. Our primary objective is to decrease the need for subsequent opioid administration. Our secondary objectives are to determine if IV Acetaminophen decreases pain score at 30 minutes, 60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the rate of adverse effects from opioids.

Interventions

  • Drug: Acetaminophen
    • Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
  • Drug: Normal saline
    • Normal saline volume equivalent

Arms, Groups and Cohorts

  • Active Comparator: Intervention
    • Patients allocated to receive IV acetaminophen
  • Placebo Comparator: Placebo
    • Patients allocated to receive IV normal saline placebo

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative Opioid Dosing
    • Time Frame: 120 minutes
    • Total dosing of opioid given after initial evaluation in mg/kg

Secondary Measures

  • Pain Scores
    • Time Frame: at disposition
    • Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
  • Inpatient Admission
    • Time Frame: 120 minutes
    • Percentage of patients admitted to the inpatient unit for parenteral pain management
  • Adverse Effects
    • Time Frame: 120 minutes
    • Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
  • Percentage of the Patients Reporting Satisfaction
    • Time Frame: 120 minutes
    • How satisfied were patients with the management of their pain

Participating in This Clinical Trial

Inclusion Criteria

  • Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher Exclusion Criteria:

  • Patient with fever (38C or 100.4F) – Patient less than age 4 years – Patient greater than age 16 years – Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen – Patient received acetaminophen within the past 4 hours – Patient with known liver disease or renal disease – Patient not requiring IV morphine (pain score 5/10 or less) – Patient enrolled in the study within the past 72 hours

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Newark Beth Israel Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cena Tejani, Principal Investigator – Newark Beth Israel Medical Center
  • Overall Official(s)
    • Cena Tejani, MD, Principal Investigator, Children’s Hospital of NJ at Newark Beth Israel Medical Center

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