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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03541980
Enrollment
71
Registered
2018-05-31
Start date
2018-02-20
Completion date
2020-02-20
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia Crisis

Keywords

sickle cell, acetaminophen in pain crises, opioid-sparing

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.

Interventions

DRUGAcetaminophen

Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen

DRUGNormal saline

Normal saline volume equivalent

Sponsors

Newark Beth Israel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Opioid Dosing120 minutesTotal dosing of opioid given after initial evaluation in mg/kg

Secondary

MeasureTime frameDescription
Percentage of the Patients Reporting Satisfaction120 minutesHow satisfied were patients with the management of their pain
Pain Scoresat dispositionScale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Inpatient Admission120 minutesPercentage of patients admitted to the inpatient unit for parenteral pain management
Adverse Effects120 minutesRate of adverse effects experienced by patients from opioid administration vs acetaminophen administration

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
35
Placebo
Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent
36
Total71

Baseline characteristics

CharacteristicInterventionPlaceboTotal
Age, Categorical
<=18 years
35 Participants36 Participants71 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
34 Participants34 Participants68 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
35 participants36 participants71 participants
Sex: Female, Male
Female
14 Participants20 Participants34 Participants
Sex: Female, Male
Male
21 Participants16 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 36
other
Total, other adverse events
0 / 350 / 36
serious
Total, serious adverse events
0 / 350 / 36

Outcome results

Primary

Cumulative Opioid Dosing

Total dosing of opioid given after initial evaluation in mg/kg

Time frame: 120 minutes

ArmMeasureValue (MEAN)
InterventionCumulative Opioid Dosing.2 mg/kg
PlaceboCumulative Opioid Dosing.2 mg/kg
Secondary

Adverse Effects

Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration

Time frame: 120 minutes

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionAdverse Effects0 Participants
PlaceboAdverse Effects0 Participants
Secondary

Inpatient Admission

Percentage of patients admitted to the inpatient unit for parenteral pain management

Time frame: 120 minutes

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionInpatient Admission25 Participants
PlaceboInpatient Admission21 Participants
Secondary

Pain Scores

Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse

Time frame: at disposition

ArmMeasureValue (MEAN)
InterventionPain Scores5.5 pain intensity measured on scale 1-10
PlaceboPain Scores5.2 pain intensity measured on scale 1-10
Secondary

Percentage of the Patients Reporting Satisfaction

How satisfied were patients with the management of their pain

Time frame: 120 minutes

ArmMeasureValue (MEAN)
InterventionPercentage of the Patients Reporting Satisfaction84 percent
PlaceboPercentage of the Patients Reporting Satisfaction85 percent

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026