Phase 4
N=225
Adult Oral Ibuprofen Study for ED Pain Patients
Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03441269 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Pain Reduction at 60 Minutes From Baseline of the 3 Oral Ibuprofen Groups — -2.12; -1.85; -1.96 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Ibuprofen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Antonios Likourezos
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Reduction at 60 Minutes From Baseline of the 3 Oral Ibuprofen Groups |
-2.12; -1.85; -1.96 | — |
| SECONDARY Rates of Adverse Event of the 3 Oral Ibuprofen Dosage Groups |
0; 0; 0 | — |
| SECONDARY Rates of Requiring Rescue Analgesia |
0; 0; 0 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03441269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.