Randomized Trial of Two Analgesics in Elderly ED Patients
- Conditions
- Pain
- Interventions
- Drug: Ibuprofen/acetaminophenDrug: Oxycodone/acetaminophen
- Registration Number
- NCT02703610
- Lead Sponsor
- Albany Medical College
- Brief Summary
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.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Complaint of acute pain of < 7 days duration
- ED attending plans to discharge patient home with an oral analgesic
- Inability to confirm reliable means of phone followup.
- Past use of methadone
- Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
- History of an adverse reaction to any of the study medications
- Ibuprofen or acetaminophen or opioids taken in past 4 hours
- History of peptic ulcer disease
- Report of any prior use of recreational narcotics
- Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibuprofen/acetaminophen Ibuprofen/acetaminophen Ibuprofen/acetaminophen (400 mg/500 mg) Oxycodone/acetaminophen Oxycodone/acetaminophen Oxycodone/acetaminophen (5 mg/325 mg)
- Primary Outcome Measures
Name Time Method Between group difference in change in NRS pain scores 24 hours Between group difference in change in NRS pain scores at 24 hours
- Secondary Outcome Measures
Name Time Method Between group difference in side effects 24 hours, 48 hours and 72 hours Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)
Change in NRS pre and 2 hours post most recent dose of pain medication taken 24 hours Change in NRS pre and 2 hours post most recent dose of pain medication taken
Satisfaction 24, 48, and 72 hours Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Between group difference in Likert pain scores 24, 48, and 72 hours Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to 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
Between group difference in change in NRS pain scores at first followup contact 24-72 hours Between group difference in change in NRS pain scores at first followup contact
Between group difference in change in NRS pain scores 48 hours and 72 hours Between group difference in change in NRS pain scores at 48 hours and 72 hours
Want same medication again 24-72 hours Between group difference in proportion of patients who would want the same medication again
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. 24-72 hours Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Trial Locations
- Locations (1)
Albany Medical College
🇺🇸Albany, New York, United States