Overview

Adult Oral Ibuprofen Study for ED Pain Patients

Status:
Completed
Trial end date:
2019-08-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Antonios Likourezos
Treatments:
Ibuprofen
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.