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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Patients allocated to receive IV acetaminophen |
|
| Placebo | Placebo Comparator | Patients allocated to receive IV normal saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Dosing | Total dosing of opioid given after initial evaluation in mg/kg | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse | at disposition |
| Inpatient Admission | Percentage of patients admitted to the inpatient unit for parenteral pain management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cena Tejani, MD | Children's Hospital of NJ at Newark Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newark Beth Israel | Newark | New York | 07112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33025690 | Derived | Dhebaria T, Sivitz A, Tejani C. Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? Acad Emerg Med. 2021 Jun;28(6):639-646. doi: 10.1111/acem.14149. Epub 2020 Oct 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients allocated to receive IV acetaminophen-35 Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen |
| FG001 | Placebo | Patients allocated to receive IV normal saline placebo-36 Normal saline: Normal saline volume equivalent |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen |
| BG001 | Placebo | Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Opioid Dosing | Total dosing of opioid given after initial evaluation in mg/kg | Posted | Mean | 99% Confidence Interval | mg/kg | 120 minutes |
|
120 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients allocated to receive IV acetaminophen Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen none |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cena Tejani | Newark Beth Israel Medical Center | 973 926 7337 | ctejani5@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2018 | Oct 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline | Drug | Normal saline volume equivalent |
|
|
| 120 minutes |
| Adverse Effects | Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration | 120 minutes |
| Percentage of the Patients Reporting Satisfaction | How satisfied were patients with the management of their pain | 120 minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Pain Scores | Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse | Posted | Mean | 99% Confidence Interval | pain intensity measured on scale 1-10 | at disposition |
|
|
|
| Secondary | Inpatient Admission | Percentage of patients admitted to the inpatient unit for parenteral pain management | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Adverse Effects | Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Percentage of the Patients Reporting Satisfaction | How satisfied were patients with the management of their pain | Posted | Mean | 99% Confidence Interval | percent | 120 minutes |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | Patients allocated to receive IV normal saline placebo Normal saline: Normal saline volume equivalent none | 0 | 36 | 0 | 36 | 0 | 36 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |