This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).
The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary outcome is the between treatment group difference in change in patients' rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients' rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Oxycodone/acetaminophen 5 mg-325 mg oral tablet
Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
Codeine/acetaminophen 30 mg-300mg oral tablet
Montefiore Medical Center
The Bronx, New York, United States
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.
Time frame: Prior to Ingestion of study medication to one hour after ingestion of the study medication
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes.
Time frame: Prior to ingestion of study medication to 2 hours after ingestion of the study medication
Percentage of Patients Who Received Rescue Medication
Number of patients who received additional analgesics divided by total number of patients x 100
Time frame: Entire two-hour time period
Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period
Time frame: End of two-hour time period
Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100
Time frame: From time of ingestion of study medication to one hour later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ibuprofen/acetaminophen 400 mg-1000mg oral tablet
ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100
Time frame: From time of ingestion of study medication to two hours later