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

Primary Purpose

Sickle Cell Anemia Crisis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Normal saline
Sponsored by
Newark Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Anemia Crisis focused on measuring sickle cell, acetaminophen in pain crises, opioid-sparing

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Newark Beth Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Patients allocated to receive IV acetaminophen

Patients allocated to receive IV normal saline placebo

Outcomes

Primary Outcome Measures

Cumulative Opioid Dosing
Total dosing of opioid given after initial evaluation in mg/kg

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2018
Last Updated
March 8, 2021
Sponsor
Newark Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03541980
Brief Title
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Official Title
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newark Beth Israel Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia Crisis
Keywords
sickle cell, acetaminophen in pain crises, opioid-sparing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients allocated to receive IV acetaminophen
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients allocated to receive IV normal saline placebo
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Ofirmev, Tylenol
Intervention Description
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sodium chloride solution
Intervention Description
Normal saline volume equivalent
Primary Outcome Measure Information:
Title
Cumulative Opioid Dosing
Description
Total dosing of opioid given after initial evaluation in mg/kg
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Time Frame
at disposition
Title
Inpatient Admission
Description
Percentage of patients admitted to the inpatient unit for parenteral pain management
Time Frame
120 minutes
Title
Adverse Effects
Description
Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Time Frame
120 minutes
Title
Percentage of the Patients Reporting Satisfaction
Description
How satisfied were patients with the management of their pain
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cena Tejani, MD
Organizational Affiliation
Children's Hospital of NJ at Newark Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newark Beth Israel
City
Newark
State/Province
New York
ZIP/Postal Code
07112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33025690
Citation
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.
Results Reference
derived

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

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