Adult Oral Ibuprofen Study for ED Pain Patients
Completed · Phase 4
Conditions studied: Pain, Acute
In brief
Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling concept that postulates that there is a dose of a drug beyond which any further dosage increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly be used at doses above its analgesic ceiling, although this may not offer an incremental analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg
Key facts
- Study ID
- NCT03441269
- Run by
- Antonios Likourezos
- People needed
- 225
- Starts
- 2018-11-01
- Expected to finish
- 2019-08-31
- Last updated by the study team
- 2020-06-04
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult ED patients aged 18 and older
- Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain intensity of less than 4 on a standard 0 to 10 numeric rating scale.
- Acute pain (within 30 days of onset)
- Patients who would routinely be treated with oral ibuprofen
You may not qualify if…
- pregnancy or breastfeeding,
- active peptic ulcer disease,
- acute gastrointestinal hemorrhage,
- known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs,
- patients having already received analgesic medication.
Where it is running
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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