Pain
Conditions
Keywords
Pain, Elderly
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)
Interventions
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
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Complaint of acute pain of \< 7 days duration * ED attending plans to discharge patient home with an oral analgesic
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in change in NRS pain scores | 24 hours | Between group difference in change in NRS pain scores at 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Between group difference in Likert pain scores | 24, 48, and 72 hours | Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe) |
| 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 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. |
| 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 |
| Want same medication again | 24-72 hours | Between group difference in proportion of patients who would want the same medication again |
| Satisfaction | 24, 48, and 72 hours | Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied |
Countries
United States
Outcome results
None listed