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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03541980
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : August 22, 2018
Information provided by (Responsible Party):
Cena Tejani, Newark Beth Israel Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Crisis Drug: Acetaminophen Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

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:
  • Ofirmev
  • Tylenol

Placebo Comparator: Placebo
Patients allocated to receive IV normal saline placebo
Drug: Normal saline
Normal saline volume equivalent
Other Name: Sodium chloride solution

Primary Outcome Measures :
  1. Cumulative Opioid dosing [ Time Frame: 120 minutes ]
    Total dosing of opioid given after initial evaluation (mg/kg)

Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 30,60,90,120 minutes ]
    A score from 0-10, with 0 being no pain and 10 being the worst pain possible.

  2. Inpatient admission [ Time Frame: 120 minutes ]
    Percentage of patients admitted to the inpatient unit for parenteral pain management

  3. Adverse Effects [ Time Frame: 120 minutes ]
    Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration

  4. Patient satisfaction [ Time Frame: 120 minutes ]
    How satisfied were patients/parents with the management of their pain

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03541980

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Contact: Cena Tejani, MD 973-926-6671
Contact: Tina Dhebaria, DO 908-472-2115

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United States, New York
Newark Beth Israel Recruiting
Newark, New York, United States, 07112
Contact: Cena Tejani    917-371-5557   
Sponsors and Collaborators
Newark Beth Israel Medical Center
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Principal Investigator: Cena Tejani, MD Children's Hospital of NJ at Newark Beth Israel Medical Center

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Responsible Party: Cena Tejani, Principal Investigator, Newark Beth Israel Medical Center Identifier: NCT03541980     History of Changes
Other Study ID Numbers: 2017.48
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Cena Tejani, Newark Beth Israel Medical Center:
sickle cell
acetaminophen in pain crises
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic