Clinical trial NCT03541980: Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Official title: Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sickle Cell Anemia Crisis
Keywords: sickle cell
acetaminophen in pain crises
opioid-sparing
Lead sponsor: Newark Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 71
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Opioid Dosing
timeFrame: 120 minutes
Secondary outcomes:
measure: Pain Scores
timeFrame: at disposition
measure: Inpatient Admission
timeFrame: 120 minutes
measure: Adverse Effects
timeFrame: 120 minutes
measure: Percentage of the Patients Reporting Satisfaction
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel
state: New York
Study officials:
affiliation: Children's Hospital of NJ at Newark Beth Israel Medical Center
name: Cena Tejani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhebaria T, Sivitz A, Tejani C. Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? Acad Emerg Med. 2021 Jun;28(6):639-646. doi: 10.1111/acem.14149. Epub 2020 Oct 30.