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

STUDY DESIGN A randomized, double-blind trial to determine the analgesic equivalency of orally administered ibuprofen at 400 mg for the treatment of acute pain in comparison to with higher doses of 600 and 800 mg for managing mild-to-moderate pain of adult patients in the ED.

OUTCOME MEASURES The primary outcome will be reduction in numeric rating scale pain score at 60 minutes from medication administration. Secondary outcomes included rates and percentages of subjects experiencing adverse effects as well as percentage of patients requiring rescue analgesia

STUDY POPULATION Patients considered for inclusion will comprise adults aged 18 and older years who presented to the ED primarily for management of acute mild to moderate musculoskeletal pain, headache, or dental pain who would routinely be treated with oral iburpofen in our ED as determined by the treating attending or resident physician. Acute pain will be defined in our study as having an onset within 30 days or less. Exclusion criteria will include pregnancy or breastfeeding, active peptic ulcer disease, acute gastrointestinal hemorrhage, known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs, and patients having already received analgesic medication. For the purposes of this study, ibuprofen will be used without co-administration of any other analgesics, with the exception of rescue medication.

STUDY LOCATION The study will be conducted at a 711-bed urban community teaching hospital with an annual ED census of greater than 120,000 visits.

DURATION OF ENROLLMENT Patients pain scores will be recorded at the beginning of the study and at 60 minutes post-administration of medication by utilizing NRS.