Phase 4
N=416
Comparative Efficacy of 4 Oral Analgesics
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02455518 ↗Enrolled (actual)
416
Serious AEs
—
Results posted
Feb 2018
Primary outcome: Primary: Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores — 4.4; 3.5; 3.9; 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxycodone/acetaminophen (Drug); Hydrocodone/acetaminophen (Drug); Codeine/acetaminophen (Drug); Ibuprofen/acetaminophen (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores |
3.1; 2.4; 2.7; 2.9 | — |
| SECONDARY Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores |
3.1; 2.4; 2.7; 2.9 | — |
Summary
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
Eligibility Criteria
Inclusion Criteria
- Complaint of acute pain of < 7 days duration
- Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
- Radiologic evaluation is planned
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
- Opioids taken in the past 24 hours
- Ibuprofen or acetaminophen taken in past 8 hours
- Pregnancy by either urine or serum HCG testing
- Breastfeeding per patient report
- 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
- Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
Data sourced from ClinicalTrials.gov (NCT02455518). 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.