Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
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 |
---|---|---|
|
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
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:
|
Placebo Comparator: Placebo Patients allocated to receive IV normal saline placebo |
Drug: Normal saline
Normal saline volume equivalent
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cumulative Opioid Dosing [120 minutes]
Total dosing of opioid given after initial evaluation in mg/kg
Secondary Outcome Measures
- Pain Scores [at disposition]
Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
- Inpatient Admission [120 minutes]
Percentage of patients admitted to the inpatient unit for parenteral pain management
- Adverse Effects [120 minutes]
Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
- Percentage of the Patients Reporting Satisfaction [120 minutes]
How satisfied were patients with the management of their pain
Eligibility Criteria
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
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)
More Information
Publications
None provided.- 2017.48
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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
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
|
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
|
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%
|
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%
|
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 | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
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
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.
Results Point of Contact
Name/Title | Dr Cena Tejani |
---|---|
Organization | Newark Beth Israel Medical Center |
Phone | 973 926 7337 |
ctejani5@gmail.com |
- 2017.48