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Current literature supports ibuprofen and APAP are the most commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and APAP in this specific setting does not exist, but instead only as it applies to pediatric patients with postoperative pain. Thus, we have designed a double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.
The investigators' hypothesize the combination of oral ibuprofen and acetaminophen (APAP) is superior to either analgesic alone plus placebo for pediatric emergency department patients with acute traumatic/non-traumatic pain
Intent to Treat, prospective, randomized, double-blind trial.
Primary outcome: Pain reduction via NRS/FACES pain scale at times 0 and 60 minutes from administration of medication(s).
Secondary outcomes: Antipyretic effects, level of analgesia achieved with each patient diagnosis(es), incidence and type of adverse effect(s), and patients' and parents' satisfaction with achieved level of analgesia.
Population : ages 3 - 17. Sample size 90 patients (30 per arm). Group 1: oral ibuprofen at 10mg/kg dose and placebo of equal volume; Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and, Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose.
Location: Urban tertiary care hospital Pediatric ED with 40,000 annual departmental visits.
Duration of Enrollment: 1 year from commencement of the study.
6/7. Patients will be enrolled and randomized upon triage by an assigned nurse dedicated to the study into one of three groups by using a blocks-randomization scheme for every 15 patients maintained by the ED pharmacists.
8. For patients experiencing breakthrough pain, oral morphine sulfate at 0.2mg/kg will be provided.
Group 1: oral ibuprofen at 10 mg/kg dose and placebo of equal volume;
Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and,
Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose. Medications including placebo will be given via prefilled syringes of identical volume, color and flavor. Level of analgesia will be assessed at times 0 and 60 minutes from administration of medication(s).
All enrolled patients, health care practitioners, and research associates will be blinded to the study medication(s) given and to the allocation sequence. Pharmacist(s) who are aware of the study medication(s) will not enroll patients. The allocation sequence code will only be revealed to the researchers once recruitment, data collection, and data entry are completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Ibuprofen | Active Comparator | Oral Ibuprofen at 10mg/kg dose and placebo of equal volume |
|
| Oral APAP | Active Comparator | Oral APAP at 15 mg/kg and placebo of equal volume |
|
| Oral Ibuprofen and Oral APAP | Active Comparator | Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Oral Ibuprofen at 10 mg/kg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 60 Minutes | Pain Score via Numeric Rating Scale or FACES pain scale at 60 minutes from baseline ( ranging from 0 to 10, with 0 being no pain, 5 being moderate pain, and 10 being very severe pain) | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Motov, MD | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Ibuprofen | Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose |
| FG001 | Oral APAP | Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose |
| FG002 | Oral Ibuprofen and Oral APAP | Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Ibuprofen | Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose |
| BG001 | Oral APAP | Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose |
| 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 | Pain Score at 60 Minutes | Pain Score via Numeric Rating Scale or FACES pain scale at 60 minutes from baseline ( ranging from 0 to 10, with 0 being no pain, 5 being moderate pain, and 10 being very severe pain) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
60 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 | Oral Ibuprofen | Oral Ibuprofen at 10mg/kg dose and placebo of equal volume Ibuprofen: Oral Ibuprofen at 10 mg/kg dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Motov, MD | Maimonides Medical Center | 7182836000 | smotov@maimonidesmed.org |
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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 | Sep 24, 2016 | Jan 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| APAP | Drug | Oral APAP at 15mg/kg dose |
|
| BG002 | Oral Ibuprofen and Oral APAP | Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Oral APAP | Oral APAP at 15 mg/kg and placebo of equal volume APAP: Oral APAP at 15mg/kg dose | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Oral Ibuprofen and Oral APAP | Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. Ibuprofen: Oral Ibuprofen at 10 mg/kg dose APAP: Oral APAP at 15mg/kg dose | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |