IBUPAP Study for Pain Management in Children

Phase 2

Completed

Conditions: Pain Management

Interventions: Drug: Ibuprofen
Drug: APAP

Registration Number: NCT03088800

Lead Sponsor: Antonios Likourezos

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Ibuprofen	Ibuprofen	Oral Ibuprofen at 10mg/kg dose and placebo of equal volume
Oral APAP	APAP	Oral APAP at 15 mg/kg and placebo of equal volume
Oral Ibuprofen and Oral APAP	Ibuprofen	Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.
Oral Ibuprofen and Oral APAP	APAP	Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.

Primary Outcome Measures

Name	Time	Method
Pain Score at 60 Minutes	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)

Secondary Outcome Measures