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

N

Newark Beth Israel Medical Center

Status and phase

Completed
Phase 4

Conditions

Sickle Cell Anemia Crisis

Treatments

Drug: Normal saline
Drug: Acetaminophen

Study type

Interventional

Funder types

Other

Identifiers

NCT03541980
2017.48

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

4 to 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

71 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Description:
Patients allocated to receive IV acetaminophen
Treatment:
Drug: Acetaminophen
Placebo
Placebo Comparator group
Description:
Patients allocated to receive IV normal saline placebo
Treatment:
Drug: Normal saline

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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