NEWS HIGHLIGHTS
Published Studies Related to Vicodin HP (Hydrocodone / Acetaminophen)
Randomized clinical trial of hydrocodone/acetaminophen versus
codeine/acetaminophen in the treatment of acute extremity pain after emergency
department discharge. [2014]
(DEA) Schedule III narcotics... CONCLUSIONS: Both medications decreased NRS pain scores by approximately 50%.
Hydrocodone/acetaminophen and tramadol chlorhydrate combination tablets for the management of chronic cancer pain: a double-blind comparative trial. [2008.01]
OBJETIVES: The purpose of this study was to compare the analgesic efficacy and tolerability of opioids hydrocodone and tramadol in the relief of cancer pain... CONCLUSIONS: There was no superior analgesic efficacy with the administration of hydrocodone/acetaminophen when compared to patients receiving tramadol in the relief of cancer pain. Tramadol produced more mild side effects than hydrocodone.
Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. [2007.04]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial. [2006.11.17]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. [2006.04]
OBJECTIVES/HYPOTHESIS: Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects. STUDY DESIGN: To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed... CONCLUSIONS: The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids.
Clinical Trials Related to Vicodin HP (Hydrocodone / Acetaminophen)
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy [Completed]
The purpose of this study is to evaluate the effectiveness (level of pain control) and
safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate
Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who
have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are
discharged from the hospital.
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers [Completed]
Comparison of Tramacet Versus Percocet in Post Surgical Patients [Not yet recruiting]
Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of
discharge following mild to moderate pain risk surgery. The following will be assessed: 1)
Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)
Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat
opioid prescription. It is expected that both groups will have similar pain outcomes but
those patients in the Percocet group will be more likely to seek a second prescription.
PK and Safety Study of XARTEMISďż˝ XR (7.5 mg Oxycodone HCl/325 mg APAP) in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain [Recruiting]
Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and
safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate
to severe acute pain. The study will assess the safety of administering multiple doses of
XARTEMIS XR in this population.
Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery [Enrolling by invitation]
Adequate pain relief has been a priority of the Joint Commission and is featured on national
inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction
with pain relief in the United States, a great deal of emphasis has been placed on opioid
pain medications. Some of this emphasis on opioid pain medication is driven by the
pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.
There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission
led to an increased incidence of prescription of opioids, but there is less evidence of
improved satisfaction with pain relief. There is some evidence of an increase in
opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has
the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the
Emergency Department for opioid overdose doubled between 2004 and 2008.
Patients in other countries take far less opioid pain medication and are equally satisfied
with pain relief. For instance, Lindenhovius et al. found in a retrospective study that
Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture
surgery and have comparable or better satisfaction with pain relief than American patients,
most of whom take oxycodone. That study was repeated prospectively (unpublished) and
confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine
use after a femur fracture demonstrated that American patients used far more than Vietnamese
patients (30 mg/kg versus 0. 9 mg/kg), but were more dissatisfied with their pain relief.
These sociological differences are striking and suggest strongly that personal factors may
be the most important determinant of satisfaction with pain relief.
It is our impression that most American hand surgeons give patients a prescription for an
opioid pain medication after carpal tunnel release, and that is certainly true in our
practice. This seems to be based primarily on the outliers, and intended to avoid
confrontation with patients that desire opioids; however, most patients take little or no
narcotic pain medication, and many who do use the opioids complain of the side
effects—nausea and pruritis in particular. It is therefore not clear whether routine opioids
is the optimal pain management strategy after carpal tunnel release. In the study of Stahl
et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal
tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use
acetaminophen or other pain medication at all after the operation.
Our aim is to determine if there is a difference in satisfaction with pain relief between
patients advised to take opioids compared to patients advised to use over the counter
acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to
determine if personal factors account for more of the variability in satisfaction with pain
relief than opioid strategy.
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