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On our radar: Pain management

Groups ask FDA to revoke approval of opioid Zohydro

More than 40 healthcare agencies, consumer organizations, addiction treatment providers and community-based drug and alcohol prevention programs called on the Food and Drug Administration to revoke its approval of the opioid Zohydro.
The medication is so powerful that a single dose could kill a child, according to a news release from Public Citizen, one of the groups that signed a letter to the FDA.

The Public Citizen news release noted that the FDA approved the drug in October against the advice of its own advisory committee, which voted 11-2 against allowing Zohydro, made by Zogenix and Alkermes, to be sold. It is the first single-ingredient hydrocodone drug ever to be approved.

Opioid prescriptions have skyrocketed in recent years, according to the news release. The U.S. includes 5% of the world’s population yet consumes more than 99% of the world’s hydrocodone. Opioid addiction and overdose deaths have increased commensurately. “I’m amazed that the FDA would approve a dangerous new opioid over the strong objection of its advisory panel,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in the release. “In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.”

Upon approving the drug, the FDA stated: “Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

Improving lighting patterns could help hospital patients

Changing the lighting patterns in hospital rooms to make the rooms more aligned with normal sleep-wake cycles could help patients feel better with less fatigue and pain, according to a small study. Esther Bernhofer, RN, PhD, of the Cleveland Clinic, and colleagues designed a study to investigate the possibility of relationships between hospital lighting, mood, sleep and pain in hospitalized adults. Between May 2011 and April 2012, the investigators collected data at a large, academically affiliated U.S. hospital. Over 72 hours, light exposure and sleep-wake patterns were continuously measured.

The researchers found hospitalized patients in the small study were exposed primarily to low levels of light 24 hours a day, indicating a lack of the natural fluctuation between bright and low light required to help maintain normal sleep-wake patterns. Also, patients slept very poorly, and the less light patients were exposed to during the day, the more fatigued they felt. The more fatigued they felt, the more pain they experienced. “Low light exposure significantly predicted fatigue and total mood disturbance,” the authors wrote.

The findings were published Oct. 27 on the website of the Journal of Advanced Nursing.

Research: Hispanic women less likely to use pain relief in labor

Hispanic women were 53% less likely to have an epidural during childbirth and 41% less likely to use a combination of epidural and IV medications for labor pain relief than women in all other racial groups, according to new research. The research, conducted by University of Virginia School of Nursing doctoral candidate Juliane Milburn, RN, PhD, FNP, examined more than 7,000 medical records from a six-year period.

Milburn also conducted 17 interviews, which revealed a number of themes about Hispanic women’s beliefs about childbirth, including that labor and childbirth are battles to be overcome; the pain of that battle is an integral part of the process and something that is better for babies; and epidurals will cause permanent back problems.

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Study: Restless sleep increases risk of pain in older adults

Nonrestorative sleep is the strongest, independent predictor of widespread pain onset among adults older than 50, according to a study by researchers in the U.K. The study, published in Arthritis & Rheumatology also found anxiety, memory impairment and poor physical health among older adults might increase the risk of developing widespread pain. Arthritis & Rheumatology is a journal of the American College of Rheumatology.

Musculoskeletal pain is more prevalent as people age, with as many as 80% of people 65 and older experiencing daily pain. Widespread pain that affects multiple areas of the body — the hallmark feature of fibromyalgia — affects 15% of women and 10% of men older than 50, according a past study in the journal Pain.

In their population-based prospective study, researchers led by John McBeth, PhD, from the Arthritis Research U.K. Primary Care Centre, at Keele University in Staffordshire, identified factors that increase the risk of the development of widespread pain in older adults. The team collected data on pain, psychological and physical health, lifestyle and demographic information from 4,326 adults older than 50 who were free of widespread pain at the start of the study — 1,562 subjects reported no pain and 2,764 had some pain.

At follow-up, 800 participants (18.5%) reported new widespread pain, results showed. The development of new widespread pain was greater in those with some pain at the start of the study; 679 (24.6%) with some pain and 121 (7.7%) of those with no pain at the start developed new widespread pain at three-year follow-up.

Analyses found pain status, anxiety, physical health-related quality of life, cognitive complaint and nonrestorative sleep were associated with increased risk of widespread pain development.

FDA: Don’t prescribe drugs with more than 325 mg acetaminophen

The Food and Drug Administration has recommended that healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen per tablet, capsule or other dosage unit. There is no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury, according to an FDA statement.

Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant and death.

“We recommend that healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen,” the FDA wrote. “We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen.”

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Exercise may ease drug-related joint pain for breast cancer patients

Women being treated with breast cancer drugs known as aromatase inhibitors can markedly ease the joint pain associated with the drugs by engaging in moderate daily exercise, according to new research. Findings from the study, conducted by investigators at the Dana-Farber Cancer Institute in Boston and Yale University in New Haven, Conn., were presented Dec. 12 during the San Antonio (Texas) Breast Cancer Symposium.

The study tracked 121 postmenopausal women who were taking aromatase inhibitors for breast cancer and who rated their joint pain as mild or greater on a standard pain-evaluation questionnaire. Researchers randomly assigned 61 of them to participate in two supervised strength-training sessions a week and to engage in an average of 150 minutes of aerobic exercise a week. The other participants followed their normal daily activities.

After a year, joint pain scores decreased by 20% among the women in the exercise group and by 3% in the other group. The severity of joint pain also decreased significantly more in those who exercised than in those who didn’t, as did the degree to which pain interfered with their lives.

“This is one of the first studies to identify an approach — particularly a non-medical approach — that can effectively lower joint pain for these patients,” Jennifer Ligibel, MD, of the Susan F. Smith Center for Women’s Cancers at Dana-Farber and the study’s senior author, said in a news release. “Exercise offers an attractive option for patients who want to continue taking these drugs but who are burdened by their side effects.”

Pre-surgical drug might ease recovery, reduce pain in pediatric patients

Administering clonidine before surgery could be a good option for controlling postop pain and also could reduce the child’s anxiety, according to a recent evidence review from the Cochrane Library. The study’s lead author, Allan Cyna, PhD, Women’s and Children’s Hospital at the University of Adelaide in Australia, said the review confirmed what he and his colleagues had observed in practice. The review found clonidine given at 4 micrograms/kg had a low number of side effects compared with other pain medications. Two potential side effects were noted — bradycardia and hypotension.

To determine whether clonidine was effective in relieving postop pain, the researchers compared the results of 11 studies, conducted in nine other countries, involving 742 children younger than 18. In four of the trials, clonidine was compared to a dummy treatment or no treatment, while six trials compared the drug with the medication midazolam and in one trial, with fentanyl.

In the trials comparing clonidine to a dummy treatment, the need for additional pain relief after surgery decreased when children were given clonidine at a 4 micrograms/kg dose before the procedure. The researchers found trials comparing clonidine with midazolam had similar results. The single trial comparing clonidine with fentanyl showed no statistically significant difference in need for additional pain relief after surgery, they found.

Because the existing studies are small and have varying methodologies, the authors called for further research “to determine under what conditions clonidine premedication is most effective in providing postoperative pain relief in children.”

Research shows sedation before nerve block boosts risk, not relief

Sedating patients before a nerve block needed to diagnose or treat chronic pain increases the costs, risks and potential for unnecessary surgeries, and sedation does not increase patient satisfaction or long-term pain control, according to new research.

“Sedation doesn’t help, but it does add expense and risk,” study leader Steven P. Cohen, MD, said in a news release. Cohen is a professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine in Baltimore. “In some places, every patient is being sedated. Our research shows it should be used very sparingly.”

Results of the new study, reported Feb. 13 on the website of the journal Pain Medicine, show sedation before a nerve block significantly increases false-positive results, meaning patients are more likely to undergo surgeries and other procedures that won’t cure the underlying pain. The increase in false-positive results can result from many factors, according to Cohen, such as the sedative medication itself relieving pain or relaxing muscles. Patients also may need to take extra time away from daily activities after being under anesthesia, while more rest alone could relieve pain.

Study abstract:

Study: Bothersome pain afflicts half of older Americans

More than half of older adults in the U.S. reported experiencing bothersome pain — often in multiple parts of the body — in the past month that impaired their physical function, according to a recent study. Longer life expectancy and aging baby boomers will increase the number of U.S. residents 65 and older to nearly 72 million over the next 25 years, according to the CDC. By 2030, older adults will make up nearly 20% of the U.S. population.

For the study, published in the December 2013 issue of the journal Pain, Patel and colleagues analyzed data from the National Health and Aging Trends Study, which was designed to investigate multiple aspects of functioning in later life. It is funded by the U.S. National Institute on Aging, part of the National Institutes of Health.

To collect the data, trained survey research staff completed in-person interviews with 7,601 adults ages 65 and older who were enrolled in the study in 2011. All participants were Medicare beneficiaries.

The findings showed the overall prevalence of bothersome pain during the past month in the study group was 52.9%. Pain did not vary across age groups, and this pattern remained unchanged when the researchers accounted for cognitive performance, dementia, proxy responses and residential-care living status.

Study abstract:

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By | 2021-04-20T13:33:35-04:00 March 20th, 2014|Categories: National|0 Comments

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