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

Sickle Cell Anemia Crisis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541980
• Other study ID #: 2017.48
• Status: Completed
• Phase: Phase 4
• Start date: February 20, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: March 2021
• Source: Newark Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia Crisis

Intervention

Drug:
• Acetaminophen
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
• Normal saline
Normal saline volume equivalent

Locations

Country	Name	City	State
United States	Newark Beth Israel	Newark	New York

Sponsors (1)

Lead Sponsor	Collaborator
Newark Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Opioid Dosing	Total dosing of opioid given after initial evaluation in mg/kg	120 minutes
Secondary	Pain Scores	Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse	at disposition
Secondary	Inpatient Admission	Percentage of patients admitted to the inpatient unit for parenteral pain management	120 minutes
Secondary	Adverse Effects	Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration	120 minutes
Secondary	Percentage of the Patients Reporting Satisfaction	How satisfied were patients with the management of their pain	120 minutes