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Best Option for Treatment of Pain Secondary to Ankle Sprain
Abstract & Commentary
By John Shufeldt, MD, JD, MBA, FACEP, Chief Executive Officer, NextCare, Inc.; Attending Physician/Vice Chair, Department of Emergency Medicine, St. Joseph's Hospital and Medical Center, Mesa, AZ, is Editor for Urgent Care Alert.
Dr. Shufeldt reports no financial relationship to this field of study.
Synopsis: This study compares Tramadol and acetaminophen to Hydrocodone and Acetaminophen versus placebo for the treatment of acute ankle sprain.
Source: Hewitt DJ, et al. Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: A randomized, placebo-controlled trial. Ann Emerg Med. 2007;49:468-480.
Pain is the leading reason for seeking care in the emergency department,1 yet it is often under- treated in the ED because of inadequate assessment and treatment, for fear of addiction.2 The goal of this study was to compare the analgesic efficacy and safety of tramadol/acetaminophen with hydrocodone/acetaminophen vs placebo in the ED, using ankle sprain with partial ligament tear as the prototypical model of acute musculoskeletal pain.
This multicenter, randomized, double blind, outpatient, placebo-controlled, parallel-group clinical trial compared 3 groups: tramadol/acetaminophen, hydrocodone/acetaminophen, and placebo. Subjects reported pain scores hourly in a diary for the first 4 hours, than daily for next 5 days. The subjects were from 47 urgent care sites and 39 emergency departments. Study subjects were adults age 18 to 75 presenting with ankle sprains from the previous 48 hours, who had a clinical diagnosis of partial ligament tear, findings of pain on ambulation, and ankle swelling.
Patients were randomized in a 1:1:1 ratio and received either 2 capsules of tramadol 37.5 mg, acetaminophen 325mg, hydrocodone 7.5 mg, acetaminophen 650 (plus one placebo capsule), or 2 placebo capsules. Tramadol/acetaminophen and hydrocodone/acetaminophen provided grater total pain relief than placebo during the first 4 hours, decreased pain intensity during the first 4 hours, and increased average pain relief on days one through 5. There was no difference in effectiveness between the tramadol/acetaminophen group as compared to the hydrocodone/ acetaminophen group. Familiar adverse side effects included nausea, vomiting, dizziness and somnolence. Hewitt and colleagues concluded that one or 2 capsules of 37.5 mg of tramadol/325 mg of acetaminophen and one capsule of 7.5 mg of Hydrocodone/ 650mg of acetaminophen were well tolerated, had equivalent clinical utility, and were both more effective than placebo in the treatment of acute ankle sprain.
This study is useful to help determine which pain medication is the best choice for the urgent care patients who present with acute musculoskeletal trauma. Like the emergency department, urgent care centers are frequented by patients who are seeking pain relief from musculoskeletal trauma.
Until this study, the typical choice for pain relief in a patient with an acute musculoskeletal injury was a non-steroidal anti-inflammatory or hydrocodone /acetaminophen, or both in combination. After this study, tramadol/acetaminophen appears to be as effective as hydrocodone/ acetaminophen for acute ankle sprain. This adds to the armamentarium of effective pain medications we can safely prescribe out of an urgent care center.
On a side note, I have noticed that many physicians are very reluctant to prescribe narcotics for the relief of acute pain for fear that this prescription will lead to addiction. However, when faced with their own acute injury, these same physicians have to no qualms about using short-term narcotic pain medication for their acutely painful injury. This dichotomy is troubling since it highlights a double standard which exists for many of us in health care. It has been shown time and again that physicians under-treat patients in pain by prescribing less pain medication than is realistically needed, or by prescribing a dosage that will not relieve the patient's painful symptoms. Perhaps now, these providers will, at minimum, prescribe an appropriate dose of the tramadol/acetaminophen combination for those patients who present in acute pain.