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

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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Anemia Crisis
• Intervention / Treatment: Drug: Acetaminophen; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Newark, New York, United States, 07112
      • Newark Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Patients allocated to receive IV acetaminophen	Drug: Acetaminophen; Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen; Other Names: Tylenol; Ofirmev
Placebo Comparator: Placebo; Patients allocated to receive IV normal saline placebo	Drug: Normal saline; Normal saline volume equivalent; Other Names: Sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Dosing	Total dosing of opioid given after initial evaluation in mg/kg	120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Newark Beth Israel Medical Center
• Investigators: Principal Investigator: Cena Tejani, MD, Children's Hospital of NJ at Newark Beth Israel Medical Center

Publications and helpful links

General Publications

• Dhebaria T, Sivitz A, Tejani C. Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? Acad Emerg Med. 2021 Jun;28(6):639-646. doi: 10.1111/acem.14149. Epub 2020 Oct 30.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: sickle cell; opioid-sparing; acetaminophen in pain crises
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2017.48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes