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Study Offers Hope of an Easier Tonsillectomy for Children

Posted on: Wednesday, 8 February 2006, 12:00 CST

Results of a U.S. study published in the January issue of Otolaryngology--Head and Neck Surgery demonstrate that children treated for enlarged tonsils with the PITA(TM) (Powered Intracapsular Tonsillectomy and Adenoidectomy) technique experience significantly less pain and a faster return to normal activity compared to children who have a traditional tonsillectomy using low energy electrocautery. Severe pain that requires medication and a slow return to normal activity are two of the most common complaints when children have their tonsils removed. More than 300,000 tonsillectomies are performed every year in the United States, mainly for chronic obstruction or infection.

The study is the largest prospective, randomized, blinded, quality of life study to be published or presented on any tonsillectomy and adenoidectomy technique. Removing tonsils significantly improved the problems caused by obstructive, enlarged tonsils for children in both study groups. However, the PITA patients recovered in 2.5 days while the electrocautery patients required four days. The PITA patients also stopped taking pain medication 2.5 days earlier than the electrocautery patients.

The study evaluated 300 children at a pediatric hospital who were more than two years old and needed a tonsillectomy solely because of obstructive, enlarged tonsils. The children were placed randomly into two groups: Half underwent a traditional tonsillectomy using electrocautery and the other half received a powered intracapsular tonsillectomy (the PITA technique). Both groups had equivalent demographics and received the same medications during surgery. The study was supported by an unrestricted grant from Medtronic.

For 14 days after surgery, each child's caretaker recorded pain levels, dosing of pain medicine, time of return to normal activity and time of return to normal diet. A validated quality of life survey was also administered before surgery and one month later, measuring physical suffering, sleep disturbance, speech or swallowing problems, emotional distress, activity limitations and caregiver concern.

Researchers found that PITA patients experienced less emotional distress and fewer activity limitations in the first four weeks after surgery compared to electrocautery patients.

"When children recover a day and a half sooner from surgery, their parents can resume their normal work schedules sooner. Likewise, when children are pain-free two and a half days sooner, parents rest better at night and can be more productive during their workday," writes Dr. Craig Derkay, FAAP, principal investigator of the study, and professor of otolaryngology--head and neck surgery and pediatrics at Eastern Virginia Medical School.

Traditional Tonsillectomy Associated with Severe Pain and Slow Recovery

Traditional tonsillectomy techniques are extracapsular, meaning all of the tonsils are removed, including the capsule that encloses the tonsils and attaches to the throat. Removing the capsule exposes the throat muscles, large blood vessels and sensitive nerves to bacterial toxins that increase pain and swelling. The surgeon also has to cauterize (burn) the throat muscles directly to stop bleeding. This combination of exposure, heat injury and bacteria significantly increases the risk for severe pain, a slow recovery and bleeding. Severe throat pain can lead to dehydration requiring rehospitalization.

The study showed that, three days after surgery, the PITA group was three times more likely to not need pain medicine and almost twice as likely to have resumed normal activity levels.

How the PITA(TM) Technique Works

The PITA method relies upon the Medtronic XPS(R) 3000 microdebrider, a surgical tool with a tiny, rotating tip. Manufactured by Medtronic ENT and available in the United States, this instrument allows the surgeon to remove tissue more precisely than traditional surgery tools. Using the microdebrider and the PITA technique, the surgeon removes 90 to 95 percent of the tonsils. A thin layer of tissue is left intact to protect the throat muscles, blood vessels and nerves. For most patients, the PITA method represents a less painful treatment, a faster return to normal diet and activity and fewer complications.

"As physicians and surgeons, it is our wish to return our patients to a state of improved health as soon as is possible. It appears that microdebrider intracapsular tonsillectomy achieves this goal more rapidly than standard tonsillectomy with the electrocautery," writes Derkay.

About Medtronic ENT

Located in Jacksonville, Fla., Medtronic ENT (www.MedtronicENT.com) is a leading developer and manufacturer of products to treat diseases of the ear, nose and throat (ENT). Patients seeking additional information about tonsils, adenoids and the PITA technique should visit www.iTonsil.com.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended October 28, 2005. Actual results may differ materially from anticipated results.

Source: Business Wire

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