Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2018
CompletedFirst Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedResults Posted
Study results publicly available
April 2, 2021
CompletedApril 2, 2021
March 1, 2021
2 years
May 17, 2018
October 15, 2020
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Opioid Dosing
Total dosing of opioid given after initial evaluation in mg/kg
120 minutes
Secondary Outcomes (4)
Pain Scores
at disposition
Inpatient Admission
120 minutes
Adverse Effects
120 minutes
Percentage of the Patients Reporting Satisfaction
120 minutes
Study Arms (2)
Intervention
ACTIVE COMPARATORPatients allocated to receive IV acetaminophen
Placebo
PLACEBO COMPARATORPatients allocated to receive IV normal saline placebo
Interventions
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Newark Beth Israel
Newark, New York, 07112, United States
Related Publications (1)
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.
PMID: 33025690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Cena Tejani
- Organization
- Newark Beth Israel Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Cena Tejani, MD
Children's Hospital of NJ at Newark Beth Israel Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 31, 2018
Study Start
February 20, 2018
Primary Completion
February 20, 2020
Study Completion
February 20, 2020
Last Updated
April 2, 2021
Results First Posted
April 2, 2021
Record last verified: 2021-03