NCT03541980

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?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Newark Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sickle Cell Anemia Crisis

Interventions

Type	Name	Description
DRUG	Acetaminophen	Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
DRUG	Normal saline	Normal saline volume equivalent

Timeline

• Start date: 2018-02-20
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2018-05-31
• Last updated: 2021-04-02
• Results posted: 2021-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study