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Turturro MA, Paris PM, Larkin GL. Tramadol versus
hydrocodone-acetaminophen in acute musculoskeletal pain: a randomized,
double-blind clinical trial. Ann Emerg Med 1998; 32:139-43.
Clinical question Is tramadol (Ultram) equivalent
to a hydrocodone-acetaminophen combination in the treatment of acute
musculoskeletal pain?
Cheap Generic Ultram (Tramadol) is available from this off-shore
pharmacy:
Tramadol
Background Tramadol is a centrally acting oral analgesic
that has both mild opioid activity and monoamine reuptake inhibition.
Indicated primarily for the treatment of chronic pain, it has been
marketed extensively to providers who manage acute pain, because
it has a low potential for abuse and no antiprostaglandin side effects.
While it has been studied in comparison with other analgesics for
postoperative pain, there have been no studies looking at comparable
efficacy for acute outpatient pain management.
Population studied The authors studied a convenience
sample of 68 adult patients, aged 18 to 70 years, presenting to
the emergency department (ED) with acute musculoskeletal pain secondary
to trauma. Exclusion criteria included having taken an analgesic
within 4 hours of arrival to the ED, pregnancy, lactation, acute
intoxication, suspected substance abuse, and a history of sensitivity
to tramadol hydrochloride or either component of hydrocodone with
acetaminophen. Patients taking monoamine oxidase inhibitors, carbamazepine,
quinidine, tricyclic compounds, or selective serotonin reuptake
inhibitors were excluded because of potential drug interactions
or risk of seizures. Patients with back pain, because of the complexity
of both the pain and the therapy, and patients who the examining
provider felt required parenteral analgesia, were also excluded.
Because of the small sample size and the evaluation of acute pain
syndromes exclusively of the musculoskeletal type, relevance to
the usual outpatient practice of family physicians is questionable.
Study design and validity This is a randomized, prospective,
double-blind, nonplacebo-controlled study comparing the analgesic
effect of tramadol hydrochloride (100 mg) to hydrocodone (5 mg)
with acetaminophen (500 mg) in acute musculoskeletal pain secondary
to trauma. No placebo control group was used because of ethical
concerns about withholding analgesics from patients with acute pain.
The capsules given to each group were identical in appearance. Pain
was evaluated at baseline and at 30, 60, 90, 120, and 180 minutes,
using a 100-mm visual analog pain scale (VAS). To reduce carryover
bias, patients were not allowed to view previously completed scales
when completing a new one. A power analysis showed that the number
of patients enrolled was adequate to ensure a 90% probability that
a VAS score difference of 30% was not because of random chance.
All comparisons between groups used intention-to-treat analysis
correctly. All other statistical tests were appropriate. The dropout
rate was less than 10% for each group.
Outcomes measured The primary outcome measured was
the interval level of pain using the VAS. Side effects were also
elicited through open-ended questioning at the end of each subject's
study period.
Results Sixty-eight subjects were enrolled in the
study. Six patients, 3 from each group, dropped out because of insufficient
analgesia (P = ns). The discharge diagnoses were similar between
groups, and included 19 distal extremity fractures, 26 sprains or
strains, and 21 contusions. Mean pain scores were similar at baseline
and improved in both groups throughout the study interval. Mean
pain scores in the hydrocodone-acetaminophen group were significantly
lower than the tramadol group at 30 minutes (51 vs 63, P = .03),
and the difference became more pronounced with each successive interval
(180 minutes: 23 vs 51, P [is less than] .01). Six patients in the
tramadol group and 4 patients in the hydrocodone-acetaminophen group
exhibited side effects, with nausea or vomiting, drowsiness or dizziness,
and anxiety reported.
Recommendations for clinical practice Compared with
hydrocodone-acetaminophen, tramadol is an inferior acute pain analgesic
for the treatment of acute musculoskeletal pain due to trauma. Tramadol's
manufacturer has reported a significant side-effect profile, with
almost 25% of patients reporting dizziness, nausea, and constipation,
and nearly 20% reporting headache or somnolence. Given the significant
cost differential between tramadol and hydrocodone-acetaminophen
and taking into account tramadol's side-effect profile, unless there
is some overriding reason to use tramadol, it should be considered
a second-line agent in this setting. Studies comparing tramadol
with other less expensive analgesics for both acute and chronic
pain in the primary care setting are needed.
Robert C. Marshall, MD, MPH
Puget Sound Family Medicine Residency
Naval Hospital
Bremerton, Washington
E-mail: fpnet@concentric.net
COPYRIGHT 1998 Dowden Health Media, Inc.
COPYRIGHT 2004 Gale Group
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