IBUPAP Study for Pain Management in Children
Condition: Pain Management
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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

        1. Intent to Treat, prospective, randomized, double-blind trial.

        2. 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.

        3. 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.

        4. Location: Urban tertiary care hospital Pediatric ED with 40,000 annual departmental
           visits.

        5. 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.
    

Intervention name(s): Ibuprofen; APAP
Intervention type(s): Drug; Drug
Intervention description(s): Oral Ibuprofen at 10 mg/kg dose; Oral APAP at 15mg/kg dose
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment