Phase 4
N=71
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Sickle Cell Anemia Crisis
Bottom Line
View on ClinicalTrials.gov: NCT03541980 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Cumulative Opioid Dosing — .2; .2 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Normal saline (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Newark Beth Israel Medical Center
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Opioid Dosing |
.2; .2 | — |
| SECONDARY Pain Scores |
5.5; 5.2 | — |
| SECONDARY Inpatient Admission |
25; 21 | — |
| SECONDARY Adverse Effects |
0; 0 | — |
| SECONDARY Percentage of the Patients Reporting Satisfaction |
84; 85 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03541980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.