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Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge . 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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Intervention_Pharmacological
hydrocodone/acetaminophen
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Intervention_Pharmacological
codeine/acetaminophen
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Intervention_Pharmacological
oral hydrocodone/acetaminophen ( 5 mg/500 mg ) to oral codeine/acetaminophen ( 30 mg/300 mg )
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Intervention_Pharmacological
hydrocodone/acetaminophen
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Intervention_Pharmacological
codeine/acetaminophen
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Intervention_Pharmacological
codeine/acetaminophen
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Intervention_Pharmacological
codeine/acetaminophen
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Outcome_Pain
Pain
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Outcome_Pain
pain
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Outcome_Adverse-effects
side-effect profiles
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Outcome_Mental
patient satisfaction
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Outcome_Other
median time from ED
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Outcome_Pain
mean NRS pain score
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Outcome_Pain
mean decrease in pain scores
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Outcome_Pain
pain
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Outcome_Adverse-effects
side effects
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Outcome_Mental
patient satisfaction
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Outcome_Pain
NRS pain scores
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Outcome_Other
superior
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Outcome_Pain
pain relief
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Participant_Condition
acute extremity pain
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Participant_Condition
acute extremity pain