title: Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge.
abstract: OBJECTIVE
  The objective was to test the hypothesis that hydrocodone/acetaminophen (Vicodin [5/500]) provides more efficacious analgesia than codeine/acetaminophen (Tylenol #3 [30/300]) in patients discharged from the emergency department (ED). Both are currently Drug Enforcement Administration (DEA) Schedule III narcotics.
  
  
  METHODS
  This was a prospective, randomized, double-blind, clinical trial of patients with acute extremity pain who were discharged home from the ED, comparing a 3-day supply of oral hydrocodone/acetaminophen (5 mg/500 mg) to oral codeine/acetaminophen (30 mg/300 mg). Pain was measured on a valid and reproducible verbal numeric rating scale (NRS) ranging from 0 to 10, and patients were contacted by telephone approximately 24 hours after being discharged. The primary outcome was the between-group difference in improvement in pain at 2 hours following the most recent ingestion of the study drug, relative to the time of phone contact after ED discharge. Secondary outcomes compared side-effect profiles and patient satisfaction.
  
  
  RESULTS
  The median time from ED discharge to follow-up was 26 hours (interquartile range [IQR] = 24 to 39 hours). The mean NRS pain score before the most recent dose of pain medication after ED discharge was 7.6 NRS units for both groups. The mean decrease in pain scores 2 hours after pain medications were taken were 3.9 NRS units in the hydrocodone/acetaminophen group versus 3.5 NRS units in the codeine/acetaminophen group, for a difference of 0.4 NRS units (95% confidence interval [CI] = -0.3 to 1.2 NRS units). No differences were found in side effects or patient satisfaction.
  
  
  CONCLUSIONS
  Both medications decreased NRS pain scores by approximately 50%. However, the oral hydrocodone/acetaminophen failed to provide clinically or statistically superior pain relief compared to oral codeine/acetaminophen when prescribed to patients discharged from the ED with acute extremity pain. Similarly, there were no clinically or statistically important differences in side-effect profiles or patient satisfaction. If the DEA reclassifies hydrocodone as a Schedule II narcotic, as recently recommended by its advisory board, our data suggest that the codeine/acetaminophen may be a clinically reasonable Schedule III substitute for hydrocodone/acetaminophen at ED discharge. These findings should be regarded as tentative and require independent validation in similar and other acute pain models.
authors.affiliation: The Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Chang
authors.forename: Polly E
authors.initials: PE
authors.lastname: Bijur
authors.forename: Kevin G
authors.initials: KG
authors.lastname: Munjal
authors.forename: E
authors.initials: E
authors.lastname: John Gallagher
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D059787:Acute Pain / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D003061:Codeine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004636:Emergency Service, Hospital; D005121:Extremities; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D010351:Patient Discharge; D017060:Patient Satisfaction; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; C526278:acetaminophen, codeine drug combination; C083640:acetaminophen, hydrocodone drug combination; D000082:Acetaminophen; D006853:Hydrocodone; D003061:Codeine