Phase 3
Completed N=720
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Analgesia After ED Discharge for Extremity Injuries
Source: ClinicalTrials.gov NCT01402375 ↗
Enrolled (actual)
720
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Difference in Pain Intensity Score Before and After Last Dose. — 7.6; 7.6; 7.9; 7.9 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Pain Intensity Score Before and After Last Dose. |
7.6; 7.6; 7.9; 7.9; 7.8; 7.6 | — |
| SECONDARY Overall Satisfaction With the Pain Medicine |
72; 66; 99; 91; 93; 97 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01402375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.