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Although patients with herpes zoster (shingles) can suffer severe acute pain for several weeks, little research has been done on effective oral treatments. In a recent randomized clinical trial involving 87 patients with moderate to severe shingles pain, researchers compared the safety and effectiveness of controlled-release (CR) oxycodone, gabapentin, and placebo. (Gabapentin is an antiepileptic drug also indicated for postherpetic neuralgia in adults.) Starting treatment within 6 days of rash onset, patients received the study drugs or placebo for 28 days. In addition, all patients received the antiviral drug famciclovir for 7 days.
Researchers found that patients taking CR oxycodone reported a significant (30%) reduction in pain compared with those in the placebo and gabapentin groups. However, nearly one-third of patients taking oxycodone withdrew from the study, most because of constipation, a common adverse reaction to opioids.
Although gabapentin didn't effectively ease acute shingles pain for patients in this study, lead researcher Robert Dworkin, PhD, says it might be more effective at a higher dose. However, because gabapentin doses must be increased gradually and shingles may clear on its own in several weeks' time, gabapentin may not be the best choice for this type of neuralgia.
Source: Dworkin RH, Barbano RL, Tyring SK, et al. A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster. Pain. 2009;142(3):209-217.
In a phase 2 clinical trial, a combination pill (polypill) containing five drugs was shown to be safe and effective in healthy people with one cardiovascular risk factor. The Polycap polypill contains low doses of hydrochlorothiazide, atenolol, ramipril, simvastatin, and aspirin.
Results of a trial involving 2,053 adults ages 45 to 80 showed the polypill could reduce cardiovascular risk by 48% and stroke by 62% in healthy people. Those who took the polypill had no more adverse reactions than eight other groups of people in the study who were taking one, two, or three of the polypill's components, and no drug-drug interactions were noted.
The degree of low-density lipoprotein cholesterol lowering was slightly less with the polypill than for simvastatin alone. The reduction in BP with the polypill was good, but less than expected given its antihypertensive components.
One benefit of the polypill would be to reduce the pill burden of patients being treated for hypertension, so researchers were disappointed that compliance was poor, with 18% of participants dropping out within 12 weeks. Researchers speculate that this may reflect problems involving medical centers unaccustomed to participating in clinical trials rather than patients' dissatisfaction with the treatment. Ongoing research will test various drug formulations and explore possible reasons for poor compliance in this trial.
Sources: The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized trial. Lancet. March 30, 2009. [Epub ahead of print]; Cannon CP. Can the polypill save the world from heart disease? Lancet. 2009;373(9672):1341-1351.
Applying a chlorhexidine gluconate-impregnated sponge (CHGIS) to intravascular catheter dressings reduced the risk of catheter-related infections in seven ICUs, according to a recently reported study. The study also found that changing unsoiled, adherent dressings every 7 days instead of every 3 days didn't increase the risk of infection.
Researchers assessed the rate of catheter-related infections in 1,636 critically ill patients who were randomly chosen to receive either standard dressings changed every 3 or 7 days, or dressings containing a CHGIS. Researchers tracked how many patients developed clinical sepsis with or without bloodstream infection.
Compared with standard dressings, those containing CHGIS reduced the rate of catheter-related infections from 1.4 to 0.6 per 1,000 catheter-days and reduced the rate of catheter-related bloodstream infections from 1.3 to 0.40 per 1,000 catheter-days. Researchers estimate that the antibacterial sponges prevented one major catheter-related infection for every 117 catheters placed. Skin tests didn't detect any increase in bacterial resistance with use of the sponges. Eight patients developed severe CHGIS-associated contact dermatitis.
The catheter colonization rate wasn't significantly different between 7-day and 3-day dressing changes (8.6% versus 7.8% respectively). Researchers concluded that "reducing the frequency of changing unsoiled adherent dressings from every 3 days to every 7 days modestly reduces the total number of dressing changes and appears safe."
Source: Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults. JAMA. 2009;301(12):1231-1241.
Two of the most commonly prescribed antiepileptic drugs (AEDs), phenytoin (Dilantin) and carbamazepine (Tegretol), may significantly increase cholesterol levels, C-reactive protein, and other markers of cardiovascular disease, new research suggests. Phenytoin and carbamazepine are powerful inducers of cytochrome P450 enzymes involved in cholesterol synthesis.
The study involved 34 patients with epilepsy who were being switched over from phenytoin or carbamazepine to one of two newer AEDs, lamotrigine or levetiracetam. These newer drugs don't activate P450 enzymes. Within 6 weeks of switching drugs, the patients had significant declines in total cholesterol, low-density lipoprotein, triglycerides, and C-reactive protein. Results were similar regardless of whether patients were switched to lamotrigine or levetiracetam.
Researchers say the improvement stemmed from taking patients off the older drugs, not from any beneficial effects on cholesterol by the newer drugs.
Source: Mintzer S, Skidmore CT, Abidin CJ, et al. Effects of antiepileptic drugs on lipids, homocysteine, and C-reactive protein. Ann Neurol. March 18, 2009 [Epub ahead of print].
Lumbar fusion surgery-a common if sometimes controversial treatment for debilitating low-back pain-is associated with low perioperative mortality, and few studies have examined the risk of death beyond the first few months of surgery. A recent study looked into mortality after lumbar fusion surgery after an average follow-up of 6.6 years. The results identified analgesic-related death as the most common cause of death among patients who died within 3 years following surgery.
Researchers studied the records of 2,378 patients claiming workers' compensation benefits who had lumbar fusion surgery between 1994 and 2001 in Washington State. By 2004, 103 of these patients had died. Analyzing the cause of death for each of these patients, researchers found that analgesics were involved in 22 (21%) of the deaths, the largest single cause of death. Of these 22 deaths, 19 were accidental overdoses and 3 were suicides. The risk of death was seven times higher for men ages 45 to 54 with degenerative disc disease than for other groups.
Researchers say the deaths reflect the high use of opioid analgesics by patients with chronic back pain, even though strong evidence of their effectiveness is lacking. They believe efforts to prevent analgesic-related deaths should focus on men with degenerative disc disease.
Source: Juratli SM, Mirza SK, Fulton-Kehoe D, et al. Mortality after lumbar fusion surgery. Spine. 2009;34(7):740-747.
Combining the angiotensin-converting enzyme inhibitor perindopril and the diuretic indapamide lowered the risk of kidney disease in people with type 2 diabetes-even those who weren't hypertensive. Researchers analyzed data from a large randomized study that included 11,140 patients with type 2 diabetes, and compared treatment with perindopril and indapamide versus treatment with a placebo. Most of the patients studied had hypertension, but 20% had BP below the usual threshold for treatment.
After an average of 4 years, the rate of kidney disease was 21% lower among patients who took the drug combination compared with those in the placebo group. Some patients who'd had early signs of diabetes-related kidney disease experienced a return to normal kidney function during drug treatment. The drugs also reduced kidney disease events among people who didn't have hypertension.
Source: de Galan BE, Perkovic V, Ninomiya T, et al. Lowering blood pressure reduces renal events in type 2 diabetes. J Am Soc Nephrol. 2009; Feb 18 [Epub ahead of print].
In a study of 26 reports published in the past 20 years, researchers found 69 people injured by accidental injection of epinephrine from an autoinjector. Indicated for patients with severe allergies, epinephrine autoinjectors are carried and used by patients to prevent or treat anaphylaxic reactions.
Most of the reported injuries (63%) occurred in the past 6.3 years. Over 90% of the injured people sustained a needle-stick injury to a finger or thumb, and 42% were injured at home.
More than 65% of injured people were evaluated in an ED. The most commonly reported treatments were warming of the injured part, application of nitroglycerin paste, and local injection of phentolamine or lidocaine. Thirteen percent of the 69 injured people weren't treated or were treated only with observation. No serious complications were reported.
Researchers say "the true rate of occurrence of unintentional injection of epinephrine is unknown but is increasing. People at risk for anaphylaxis need regular coaching in how to use epinephrine autoinjectors correctly and safely." They also call for improvements in autoinjector design to minimize risks.
Simons FER, Lieberman PL, Read EJ, Edwards ES. Hazards of unintentional injection of epinephrine from autoinjectors: a systematic review. Ann Allergy Asthma Immunol. 2009;102:267-272.
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