Tramadol Versus Hydrocodone-Acetaminophen in Acute Musculoskeletal Pain: A Randomized, Double-Blind Clinical Trial,☆☆,,★★

Presented at the American College of Emergency Physicians Research Forum, San Francisco, CA, October 1997.
https://doi.org/10.1016/S0196-0644(98)70127-1Get rights and content

Abstract

Study objective: To evaluate the efficacy of an oral tramadol preparation versus that of an oral hydrocodone-acetaminophen preparation in acute musculoskeletal pain.

Methods: A randomized, prospective, double-blind clinical trial was conducted in an urban teaching emergency department with an annual census of 41,000. Participants comprised a convenience sample of 68 adult ED patients with acute musculoskeletal pain caused by minor trauma. Thirty-three patients received tramadol (100 mg), and 35 patients received hydrocodone-acetaminophen (5 mg hydrocodone with 500 mg acetaminophen). The drugs were prepared in identical-appearing capsules. Pain was evaluated by a 100-mm visual analog scale (VAS) at baseline and at 30, 60, 90, 120, and 180 minutes after dosing. VAS scores were analyzed by 2-way repeated-measures ANOVA, and nominal data were analyzed by Fisher’s exact test.

Results: Mean pain scores did not differ at baseline (tramadol, 68.3 ±21.8; hydrocodone-acetaminophen, 69.1±17.8; P=NS) but were significantly lower in the hydrocodone-acetaminophen group beginning at 30 minutes through 180 minutes. There were 6 dropouts as a result of reported inadequate analgesia, 3 in each group (P=NS). The discharge diagnoses and prevalence of side effects did not differ significantly between groups.

Conclusion: Tramadol provides inferior analgesia to hydrocodone- acetaminophen in ED patients with acute musculoskeletal pain.

[Turturro MA, Paris PM, Larkin GL: Tramadol versus hydrocodone-acetaminophen in acute musculoskeletal pain: A randomized, double-blind clinical trial. Ann Emerg Med August 1998;32:139-143.]

Section snippets

INTRODUCTION

Tramadol hydrochloride is a centrally acting analgesic that has been available as an oral preparation in the United States since 1995, and in Germany since 1977 as an unrestricted analgesic agent. Its mechanism of action involves both low-affinity binding to the μ-opioid receptor and inhibition of monoamine reuptake,1 the latter of which may make this agent suitable for the treatment of chronic pain. Its opioid agonist properties appear to be minor, which may limit its effectiveness in the

MATERIALS AND METHODS

This study was approved by the hospital’s Research and Human Rights Committee, and written informed consent was obtained from each patient before enrollment. A convenience sample of adult ED patients, aged 18 to 70 years, with acute musculoskeletal pain caused by trauma were used as study subjects. Patients who had taken any analgesic within 4 hours of arrival at the ED were excluded, as were patients with known pregnancy, lactation, acute intoxication, suspected substance abuse, or a history

RESULTS

Sixty-eight subjects were enrolled in the study. Six patients, 3 from each group, dropped out of the study because of insufficient analgesia (P=NS).

The ED discharge diagnoses were similar between groups (Table 1). With the exception of 1 patient with a suspected rib fracture in the hydrocodone with acetaminophen group, all fractures were of the distal extremities.

Mean pain scores were similar at baseline and improved in both groups throughout the course of the study, but they were significantly

DISCUSSION

Tramadol hydrochloride is a unique opioid analgesic in that it has both direct opioid agonist properties, because of low-affinity binding to the μ-opioid receptor, and effects similar to the tricyclic compounds in its inhibition of monoamine reuptake. This may explain its effects in both acute and chronic pain. However, because the direct opioid agonist properties are less pronounced, the analgesic effect of tramadol hydrochloride in patients with acute pain may be less than that of other

Acknowledgements

The authors thank Chris Connor and Susan Mathias for their invaluable assistance in the completion of this work.

References (13)

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From the Department of Emergency Medicine, The Mercy Hospital of Pittsburgh,* and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.

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Support by the Emergency Medicine Association of Pittsburgh.

Reprint no. 47/1/91521

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Address for reprints: Michael A Turturro, MD Emergency Medicine Association of Pittsburgh 13 Pride Street Pittsburgh, PA 15219 412-232-5765 Fax 412-232-5768 E-mail [email protected]

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