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

• Sponsor: Newark Beth Israel Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03541980
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Anemia Crisis	Drug: Acetaminophen; Drug: Normal saline	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
• Actual Study Start Date: Feb 20, 2018
• Actual Primary Completion Date: Feb 20, 2020
• Actual Study Completion Date: Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Patients allocated to receive IV acetaminophen	Drug: Acetaminophen; Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen; Other Names: Ofirmev Tylenol
Placebo Comparator: Placebo Patients allocated to receive IV normal saline placebo	Drug: Normal saline; Normal saline volume equivalent; Other Names: Sodium chloride solution

Outcome Measures

Primary Outcome Measures

1. Cumulative Opioid Dosing [120 minutes]

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

Secondary Outcome Measures

1. Pain Scores [at disposition]

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

2. Inpatient Admission [120 minutes]

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

3. Adverse Effects [120 minutes]

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

4. Percentage of the Patients Reporting Satisfaction [120 minutes]

   How satisfied were patients with the management of their pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Newark Beth Israel	Newark	New York	United States	07112

Sponsors and Collaborators

• Newark Beth Israel Medical Center

Investigators

• Principal Investigator: Cena Tejani, MD, Children's Hospital of NJ at Newark Beth Israel Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 1, 2018

More Information

Publications

None provided.

• Responsible Party: Cena Tejani, Principal Investigator, Newark Beth Israel Medical Center
• ClinicalTrials.gov Identifier: NCT03541980
• Other Study ID Numbers: 2017.48
• First Posted: May 31, 2018
• Last Update Posted: Apr 2, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cena Tejani, Principal Investigator, Newark Beth Israel Medical Center: sickle cell; acetaminophen in pain crises; opioid-sparing
• Additional relevant MeSH terms: Anemia, Sickle Cell; Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen-35 Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen	Patients allocated to receive IV normal saline placebo-36 Normal saline: Normal saline volume equivalent
Period Title: Overall Study
STARTED	35	36
COMPLETED	35	36
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Placebo	Total
Arm/Group Description	Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen	Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent	Total of all reporting groups
Overall Participants	35	36	71
Age (Count of Participants)
<=18 years	35 100%	36 100%	71 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	14 40%	20 55.6%	34 47.9%
Male	21 60%	16 44.4%	37 52.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	34 97.1%	34 94.4%	68 95.8%
White	0 0%	0 0%	0 0%
More than one race	1 2.9%	2 5.6%	3 4.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%	36 100%	71 100%

Outcome Measures

1. Primary Outcome

Title	Cumulative Opioid Dosing
Description	Total dosing of opioid given after initial evaluation in mg/kg
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen .2mg/kg	Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent .2mg/kg
Measure Participants	35	36
Mean (99% Confidence Interval) [mg/kg]	.2	.2

2. Secondary Outcome

Title	Pain Scores
Description	Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Time Frame	at disposition

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen 5.5	Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent 5.2
Measure Participants	35	36
Mean (99% Confidence Interval) [pain intensity measured on scale 1-10]	5.5	5.2

3. Secondary Outcome

Title	Inpatient Admission
Description	Percentage of patients admitted to the inpatient unit for parenteral pain management
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen	Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent
Measure Participants	35	36
Count of Participants [Participants]	25 71.4%	21 58.3%

4. Secondary Outcome

Title	Adverse Effects
Description	Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen-35 Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen	Patients allocated to receive IV normal saline placebo-36 Normal saline: Normal saline volume equivalent
Measure Participants	35	36
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Percentage of the Patients Reporting Satisfaction
Description	How satisfied were patients with the management of their pain
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen-35 Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen	Patients allocated to receive IV normal saline placebo-36 Normal saline: Normal saline volume equivalent
Measure Participants	35	36
Mean (99% Confidence Interval) [percent]	84	85

Adverse Events

Time Frame	120 minutes
Arm/Group Title	Intervention		Placebo
Arm/Group Description	Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen none		Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent none
All Cause Mortality
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)
Serious Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.