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Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge.
Acad Emerg Med. 2014 Mar; 21(3):227-35.AE

Abstract

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.

Authors+Show Affiliations

The Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24628747

Citation

Chang, Andrew K., et al. "Randomized Clinical Trial of Hydrocodone/acetaminophen Versus Codeine/acetaminophen in the Treatment of Acute Extremity Pain After Emergency Department Discharge." Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine, vol. 21, no. 3, 2014, pp. 227-35.
Chang AK, Bijur PE, Munjal KG, et al. Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge. Acad Emerg Med. 2014;21(3):227-35.
Chang, A. K., Bijur, P. E., Munjal, K. G., & John Gallagher, E. (2014). Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge. Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine, 21(3), 227-35. https://doi.org/10.1111/acem.12331
Chang AK, et al. Randomized Clinical Trial of Hydrocodone/acetaminophen Versus Codeine/acetaminophen in the Treatment of Acute Extremity Pain After Emergency Department Discharge. Acad Emerg Med. 2014;21(3):227-35. PubMed PMID: 24628747.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge. AU - Chang,Andrew K, AU - Bijur,Polly E, AU - Munjal,Kevin G, AU - John Gallagher,E, PY - 2013/07/11/received PY - 2013/09/03/revised PY - 2013/09/13/revised PY - 2013/09/16/accepted PY - 2014/3/18/entrez PY - 2014/3/19/pubmed PY - 2014/9/30/medline SP - 227 EP - 35 JF - Academic emergency medicine : official journal of the Society for Academic Emergency Medicine JO - Acad Emerg Med VL - 21 IS - 3 N2 - 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. SN - 1553-2712 UR - https://www.unboundmedicine.com/medline/citation/24628747/Randomized_clinical_trial_of_hydrocodone/acetaminophen_versus_codeine/acetaminophen_in_the_treatment_of_acute_extremity_pain_after_emergency_department_discharge_ L2 - https://doi.org/10.1111/acem.12331 DB - PRIME DP - Unbound Medicine ER -