Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03088800 |
| Other study ID # |
2017-01-06 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2018 |
| Est. completion date |
July 30, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
