Randomized clinical trial of hydrocodone/acetaminophen versus
codeine/acetaminophen in the treatment of acute extremity pain after emergency
department discharge.
Author(s): Chang AK(1), Bijur PE, Munjal KG, John Gallagher E.
Affiliation(s): Author information:
(1)The Department of Emergency Medicine, Albert Einstein College of Medicine,
Montefiore Medical Center, Bronx, NY.
Publication date & source: 2014, Acad Emerg Med. , 21(3):227-35
OBJECTIVES: 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.
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