Adult Oral Ibuprofen Study for ED Pain Patients
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      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.

      DESCRIPTION OF INTERVENTION AND ADMINISTRATION Once the patient is triaged, an initial pain
      score will be assessed. Patients will then have an initial evaluation by ED physician and,
      once deemed eligible for the study, the patient will be randomized to receive oral ibuprofen
      at a dose of 400mg, 600mg, or 800mg. The on-duty ED pharmacist will prepare 400 mg, 600 mg
      and 800 mg oral ibuprofen preparations in identical capsules according to predetermined
      randomization generated in SPSS by the research manager. Demographics, chief complaint and
      initial pain score will be recorded in the data sheet as well as prior analgesics use.
      Patients pain scores will be recorded at the beginning of the study and at 60 minutes
      post-administration by using NRS.

      RANDOMIZATION/BLINDING The research manager and statistician independently of data collection
      will conduct the programming of the randomization list, confirmation of written consent
      acquisition, and statistical analyses. ED pharmacy investigators will maintain the
      randomization list, prepare the medication, and deliver it to the nurse caring for the study
      participant in a blinded manner. The preparing pharmacist, research manager, and statistician
      will be the only ones with knowledge of the study arm to which the participant would be
      randomized. Providers, participants, and the data-collecting research team will be blinded to
      the medication received. Study investigators will include treating physicians who will
      assisted in screening and supervising the research fellow, residents, and research
      coordinators, who will enroll patients and record pain scores and adverse effects at baseline
      and at 60 minutes.
    

Intervention name(s): Oral Ibuprofen
Intervention type(s): Drug
Intervention description(s): Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emergency Medicine; Acute Pain; Oral Ibuprofen