CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 225 enrolled
Drug / intervention
Oral Ibuprofendrug
Likely dose
Oral Ibuprofen 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03441269
NCT03441269Phase 4Completed

A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Oral Ibuprofen in Management of Mild to Moderate Pain in Adult Patients in the ED

Antonios Likourezos·interventional·Posted Feb 22, 2018·Updated Jun 4, 2020

In Brief

A Phase 4 clinical trial evaluating Oral Ibuprofen for Pain, Acute. Completed, enrolled 225 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Acute
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartNov 1, 2018
Primary CompletionJun 30, 2019
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.4 years ago

Interventions

Oral Ibuprofendrug

Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg