IBUPAP Study for Pain Management in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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IBUPAP - Combination of Oral Ibuprofen and Acetaminophen (APAP) is Superior to Either Analgesic Alone for Pediatric Emergency Department (ED) Patients With Acute Pain

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: APAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 3-17 years old presenting to the pediatric ED treating physician deems patient required ibuprofen Tylenol or both for pain relief Exclusion Criteria: documented or suspected pregnancy, (2) parental refusal, allergies to NSAIDS or APAP inability to tolerate oral medications or contraindications to oral medication route received analgesics within 4 hours prior to ED presentation inability to use pain scales

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Ibuprofen<br>Oral Ibuprofen at 10mg/kg dose and placebo of equal volume | Drug: Ibuprofen<br>* Oral Ibuprofen at 10 mg/kg dose<br>|
| Active Comparator: Oral APAP<br>Oral APAP at 15 mg/kg and placebo of equal volume | Drug: APAP<br>* Oral APAP at 15mg/kg dose<br>|
| Active Comparator: Oral Ibuprofen and Oral APAP<br>Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose. | Drug: Ibuprofen<br>* Oral Ibuprofen at 10 mg/kg dose<br>Drug: APAP<br>* Oral APAP at 15mg/kg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |