drugset / Trial / NCT03441269

Adult Oral Ibuprofen Study for ED Pain Patients

NCT03441269 ↗

Phase 4 Completed 225 enrolled Antonios Likourezos
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2018-11-01
Primary completion
2019-06-30
Completion
2019-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 400 mg Oral
Comparator Ibuprofen Small molecule 600 mg Oral
Comparator Ibuprofen Small molecule 800 mg Oral

Indications

No indication recorded.