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

NCT03541980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-04-02

Study results available
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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.

Conditions

  • Sickle Cell Anemia Crisis

Interventions

DRUG

Acetaminophen

Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen

DRUG

Normal saline

Normal saline volume equivalent

Sponsors & Collaborators

  • Newark Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Cena Tejani, MD · Children's Hospital of NJ at Newark Beth Israel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541980 on ClinicalTrials.gov