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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
Normal saline volume equivalent
Newark Beth Israel
Newark, New York, United States
Cumulative Opioid Dosing
Total dosing of opioid given after initial evaluation in mg/kg
Time frame: 120 minutes
Pain Scores
Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Time frame: at disposition
Inpatient Admission
Percentage of patients admitted to the inpatient unit for parenteral pain management
Time frame: 120 minutes
Adverse Effects
Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Time frame: 120 minutes
Percentage of the Patients Reporting Satisfaction
How satisfied were patients with the management of their pain
Time frame: 120 minutes
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