Analgesia After ED Discharge for Extremity Injuries Clinical Trial
Official title:
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge
Verified date | April 2018 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There will be 3 randomized, double-blinded clinical trials to help determine which of commonly prescribed oral opioid combination is most effective in managing acute extremity pain after discharge from the adult emergency department. The first trial compares hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.
Status | Completed |
Enrollment | 720 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 64 Years |
Eligibility |
Inclusion Criteria: - patient has complaint of acute extremity pain (less than 7 days duration) - clinician plans to discharge on oral pain medication Exclusion Criteria: - patients on methadone - chronic pain condition such as sickle cell anemia or fibromyalgia - history of adverse reaction to one of the study medications - taken prescribed opioids in the past 24 hrs - have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease) - Take a medication that might interact with one of the study medications |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Pain Intensity Score Before and After Last Dose. | Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken. | 2 hrs | |
Secondary | Overall Satisfaction With the Pain Medicine | Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication. | 24 hrs |