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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?

Conditions
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Sickle Cell Anemia Crisis

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Patients allocated to receive IV acetaminophen | Drug: Acetaminophen<br>* Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen<br>* Other names: Tylenol;|
| Placebo Comparator: Placebo<br>Patients allocated to receive IV normal saline placebo | Drug: Normal saline<br>* Normal saline volume equivalent<br>* Other names: Sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Opioid Dosing | Total dosing of opioid given after initial evaluation in mg/kg | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse | at disposition | 
| Inpatient Admission | Percentage of patients admitted to the inpatient unit for parenteral pain management | 120 minutes | 
| Adverse Effects | Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration | 120 minutes | 
| Percentage of the Patients Reporting Satisfaction | How satisfied were patients with the management of their pain | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell, acetaminophen in pain crises, opioid-sparing