CRAIG T. KOJIMA / CKOJIMA@STARBULLETIN.COM Kassandra Kea is checked by Dr. Ellen Raney at Shriners Hospital after an operation to straighten her left leg. She was one of 16 patients in a pilot study at Shriners on the use of Botox to reduce pain after surgery.

Botox might relieve pain in child surgery

A popular drug used cosmetically to fight wrinkles is being tested as a pain medicine for children undergoing limb lengthening or orthopedic corrections at Shriners Hospitals for Children.

"The project is very exciting because Botox (Botulinum toxin type A) relaxes muscles," said Dr. Ellen Raney, orthopedic surgeon and principal investigator of the study at Shriners' Honolulu hospital.

"A lot of what we're doing is about stretching the muscles, and since Botox relaxes the muscles, patients have less pain and faster return to recovery."

Ramona Fillman, research coordinator, said a two-year pilot phase began in 2004 for 16 patients and the Honolulu hospital was approved for 32 children in an expanded study that began in January.

The patients' quality of life, amount of pain, physical function and how fast they're up and back to normal activities is being evaluated, she said.

The Montreal Shriners Hospital launched the study to see whether Botox is helpful because physicians around the world had reported using it for pain management, Fillman said.

Besides Honolulu and Montreal Shriners hospitals, those in Portland and Philadelphia, the Hospital for Sick Children in Toronto and DuPont Institute in Delaware are participating in the study.

Patients ages 5 to 21 years old undergoing any limb lengthening or surgery for lower-extremity orthopedic deformities are eligible for the study.

Patients are assigned randomly to Botox or a placebo (saline water), which is injected into their muscles at the time of surgery, Raney said.

All patients are offered pain medications, and they can push a button to get medicine the first few days after surgery, she said. "We will chart the level of pain in a diary and how much pain medicine they ask for."

The study is being done independently of the company that sells the drug, Raney said. It will involve a total of about 150 children and is targeted for completion in December 2009.

"If it becomes clear that it's (Botox) a big advantage, we can actually stop the study and begin using it."

Botox has been used for many years to treat muscle spasticity in children with cerebral palsy. It also has been injected into muscles around the skull to relieve headaches, Raney said.

Only the one injection at surgery is given and only the Shriners pharmacist and statistician know whether it is Botox or a placebo, Fillman said.

Patients receive standard care and physical therapy and are followed for three months after the corrective procedure, she said.

Families are asked to complete questionnaires about the child's pain, quality of life and other aspects.

Results of the pilot study haven't been released, but "some indicators are looking very positive," Fillman said.

Girl recovering with little pain after surgery to straighten leg

The 12-year-old didn't even wince when the orthopedic surgeon at Shriners Hospitals for Children tightened a contraption on her left leg to lengthen and straighten it.

It was just another step in Kassandra Kea's long recovery from an accident on Thanksgiving 2000.

She was riding her bicycle when she was struck by a car reversing in the driveway, said her mother, Melissa Espe. The driver's visibility was blocked by high mock orange bushes, she said.

The child was rushed to Wahiawa General Hospital and then to the Queen's Medical Center, where surgery was performed on broken femurs in both legs and a crushed left knee. She was in the intensive care unit 11 days.

Kassandra has been to the operating room many times at Queen's and at Shriners, where she was admitted in September 2001.

She underwent several operations on her leg by Dr. Suzanne Yandow, former Shriners orthopedic surgeon. She became Dr. Ellen Raney's patient in March 2003.

Because of the severity of the injury, her knee stopped growing and her leg grew crooked, Raney said. "It was shorter and very crooked. Now it is nice and straight."

Kassandra was one of 16 patients in a pilot study at Shriners on the use of Botox to reduce pain after surgery.

Raney gave her an injection after cutting the femur in her left leg and applying an Ilizarov device Dec. 5 to straighten it and make it longer. It isn't known whether Kassandra received Botox or a placebo, because it's a randomized blind study.

The Ilizarov apparatus, named for the Russian inventor, consists of pins placed through the bone and attached to a series of metal rings and rods outside the leg. "We call it a bird cage," Raney said.

The rods must be turned 1 millimeter each day, which Kassandra can do herself.

She said she doesn't remember whether she had a lot of pain, but her mother said she took very little pain medicine. "She said it made her sick," Raney said.

X-rays show the bone in Kassandra's leg is "nice and solid" again, and it may be possible to remove the Ilizarov device in about three weeks, Raney said. Her patient will have to work on knee motion, she said: "It has gotten a little stiff."

A certified nurse's aide, Espe said Kassandra, youngest of five children, has been a good patient throughout her long ordeal. "She spices up everybody. She's very cheerful, very helpful and very forward. She tells you straight."