The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.
To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows: 1. Oxycodone/acetaminophen (5/325) 2. Ibuprofen/acetaminophen (400/500)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen
Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen
Albany Medical College
Albany, New York, United States
Between group difference in change in NRS pain scores
Between group difference in change in NRS pain scores at 24 hours
Time frame: 24 hours
Between group difference in change in NRS pain scores at first followup contact
Between group difference in change in NRS pain scores at first followup contact
Time frame: 24-72 hours
Between group difference in change in NRS pain scores
Between group difference in change in NRS pain scores at 48 hours and 72 hours
Time frame: 48 hours and 72 hours
Between group difference in side effects
Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)
Time frame: 24 hours, 48 hours and 72 hours
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Time frame: 24 hours
Between group difference in Likert pain scores
Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)
Time frame: 24, 48, and 72 hours
Satisfaction
Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Time frame: 24, 48, and 72 hours
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
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Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Time frame: 24-72 hours
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Time frame: 24-72 hours
Want same medication again
Between group difference in proportion of patients who would want the same medication again
Time frame: 24-72 hours