Pain Patch a Welcome Change for Children
November 18, 2005
A transdermal patch delivering fentanyl (Duragesic) seems to be a safe and effective alternative for managing chronic pain in children, according to a new study. The patch is particularly useful for children who fear injections or who have difficulty swallowing pills.
The study by JC Finkel, MD, of the Children's National Medical Center in Washington DC, and colleagues was published in Cancer online and reported by MedPage Today on 14 November 2005.
Study results showed that 50% of children who were switched to the Duragesic (fentanyl transdermal system) patch reported good pain-control. Of these, 37% reported an improvement, according to Dr Finkel.
The study was published four months after the US Food and Drug Administration (FDA) issued a warning that patients had died from drug overdoses while using the Duragesic patch, as well as the generic version of the fentanyl patch, manufactured by Mylan Laboratories.
The FDA cautioned physicians to prescribe the lowest possible dose required for pain-relief.
Clinical Study
Researchers evaluated the patch in 173 pediatric patients, aged 2-16 years, over a period of 15 days, with an optional 3-month extension. Participants had malignant and non-malignant disease and were receiving oral or parenteral opioids for moderate to severe pain.
The patients' daily morphine dose determined initial daily dosages of fentanyl (mean initial daily fentanyl dosage = 0.98 mcg/kg/hour). Dosages were titrated upward as needed until steady-state pain-relief occurred; the average final dose was 1.20 mcg/kg/hour.
The researchers assessed patients' quality of life and degree of pain at baseline, at regular intervals and on day 16, and they monitored adverse events on days 1-15. Average daily pain-intensity levels were reported by the children or their parents on a 10-point scale.
On another scale, the 100-point Play Performance Scale, the average score increased by an average of 11.5%. This degree of improvement represented a change from "mostly in bed and participating only in quiet activities" to "gets dressed but lies around much of the day, no active play but is able to participate in quiet play," according to MedPage Today.
Most patients reported good or improving pain-relief. However, about 10% of patients whose pain-relief prior had been poor prior to receiving the patch reported continued poor pain-relief on the patch. Nearly 3% of patients reported worse pain-relief with the patch.
Immediately after conversion to the patch, more than 80% of the total daily opioid requirement was delivered by transdermal fentanyl. The use of rescue medication reached a stable daily total within two patch applications, indicating that the proposed titration algorithm can be used successfully.
In total, approximately 65% of study subjects participated in the optional extension period.
The most frequent adverse events related to the trial medication included emesis (16.1%), nausea (10.6%), pruritus (7.5%), application-site reaction (7.5%), headache (7.0%), constipation (6.0%) and somnolence (5.5%).
Serious adverse events related to the study treatment occurred in 19 patients (9.5%) and included emesis (2.5%), pain (2%), dyspnea (1.5%), somnolence (1%) and neuroblastoma (0.5% or one patient).
Four patients experienced respiratory system-related adverse events likely to have been associated with treatment. All of these patients recovered within 1-2 days and continued to use the patch.
"The adverse events observed in the current study are consistent with those of a potent opioid and a study population with serious and often progressive and life-threatening disease," said the authors. "There were no adverse events associated with transdermal fentanyl that indicated a specific risk in this pediatric population."
They concluded, "Results from global assessments of pain treatment, safety, and quality of life indicate that transdermal fentanyl is an acceptable alternative to oral opioid therapy in children. Transdermal fentanyl is especially useful for good pain management in children with life-limiting conditions in whom oral or injectable routes of drug delivery are difficult to administer or would add further distress."
The study was supported by Johnson & Johnson, who manufacture the Duragesic patch.
FDA Warning
In the FDA's warning issued last July, the FDA said that"signs of overdose include difficulty breathing; extreme fatigue and sedation; inability to think, talk, or walk normally; and feeling faint, dizzy or confused," according to MedPage Today. Patients who experience any of these symptoms should immediately seek medical help, the FDA said.
Additionally, the FDA advised physicians to inform patients about correct storage and disposal of fentanyl patches. The fentanyl patches must be kept out of the reach of children and not thrown out in the bathroom or household trash. Patches that have been used or are unneeded or defective should be disposed of by folding the patch so the patch's sticky side sticks to itself, then flushing the discarded patch down the toilet.
Sources:
Pain
Patch Wins High Marks In Children, MedPage Today, 14 November
2005.
Transdermal fentanyl in the management of children with chronic
severe pain: Results from an international study, Finkel JC et
al. Cancer, Early View (Articles online in advance of
print), 14 November 2005.
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