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New Study Shows Pre-Operative Sedative Helps Children To Recover From Fear Of SurgeryPatients given a formulation of VERSED(R) had fewer nightmares and negative behavioral changes after surgery |
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NEW HAVEN, Conn., April 13, 1999 -- Before her operation,
three-year-old Gabriella D'Angelo was a sweet, cuddly child with a
cherubic
smile and a voracious appetite. But after a routine adenoidectomy, this
North
Branford, Connecticut toddler became cranky and disobedient. Although her
operation had been a smooth, successful one, Gabriella remained
traumatized by
her fear of the surgery.
"When we brought Gabriella home from the hospital, it was like we were bringing home a different person," said Gabriella's mother, Lisa D'Angelo. "Gabriella wasn't my little angel. Instead, she was hostile, angry, and refused to eat. She didn't want to play with me, and couldn't seem to concentrate on puzzles that she had previously done with her eyes closed. I couldn't believe that this was my daughter." New clinical research shows that if Gabriella had been given a sedative before surgery, her negative post-operative reactions might have been prevented. This research, which was published in a recent edition of Anesthesiology, demonstrated that giving children a sedative prior to administration of general anesthesia for surgery not only reduces pre-operative anxiety, but also may improve post-operative behavioral outcomes. The results showed that children who were premedicated before surgery experienced fewer negative reactions to the operation, such as bed-wetting and loss of appetite, than those patients who were not premedicated. "Surgery is a traumatic event, and for children, the memory of the experience endures long after the operation. Up to a week later, children can still exhibit aggressive behavior resulting from their fear of surgery," said Zeev N. Kain, M.D., lead study investigator and Chief of Pediatric Anesthesiology, Department of Anesthesiology, Yale University School of Medicine; and Medical Director, Pediatric Surgery Center, Yale-New Haven Hospital, New Haven, Connecticut. "To help ensure a smooth recovery, these results suggest that it is in everyone's best interest to use all available methods to comfort children before surgery." Study shows post-operative benefits of premedication The study, which was conducted at the Yale University School of Medicine, looked at 86 children, ages 2 to 7, who received general anesthesia prior to a surgical procedure. The randomized, double-blind, controlled study excluded all children who had experienced stressful life events, such as illness or divorce. (This screening process was necessary to rule out the effects of external situations on a child's anxiety level.) The trial investigated the effects of premedicating the patients with a formulation of VERSED(R) (midazolam) on pre-operative anxiety. Dr. Kain's study found that one week after surgery, post-operative anxiety was reduced by half in the children who were premedicated with VERSED in the pre-operating holding room, compared to children treated only with placebo. Jennie Murphy, whose six-year-old daughter Emilie recently underwent double-hernia repair surgery, attested to the benefits of premedication with VERSED. "Emilie really responded well to the sedative that she received just before the anesthesia. She was relaxed and giggling, and was not at all apprehensive at the time of separation. After the surgery, she recovered very well and didn't have any side effects or nightmares." Because surgery is a frightening experience for children, it can dramatically affect their behavior. A normally calm, quiet child may lash out at his or her parents, and be aggressive or hostile. Nightmares, bed-wetting, loss of appetite, and temper tantrums also are common reactions to surgery. "Nearly three million children undergo surgery each year, yet more than 62% are not premedicated," said Dr. Kain. "Children can benefit from a sedative like VERSED before administration of general anesthesia, because their pre-operative mental state can be a major determinant of their mood and behavior after surgery." Easing a child's fear of surgery Dr. Kain offers the following advice to parents to help ease worries about pediatric surgery: "As surgical patients, children are special people with special considerations," said Dr. Kain. "Recognizing these needs, and using all available tools to alleviate children's anxiety related to surgery, has now been shown to have measurable benefits to the child and parents that will last long after the surgery is completed." "After seeing what Gabriella went through after her surgery, I've promised myself that from now on, when one of my daughters requires surgery -- or any scary medical procedure -- I am going to insist that she receives a sedative to reduce her anxiety, and mine," said Lisa D'Angelo. For more information about how to prepare children for surgery, and a free copy of the "Rest Assured" brochure, which explains pediatric surgery, call Roche Laboratories 877-853-7750. About VERSED and VERSED Syrup VERSED, which is made by Hoffmann-La Roche, Inc., has been approved by the FDA for use as a pre-operative sedative in emergency rooms and during many medical procedures, as well as in general surgery. VERSED also has an amnestic quality that reduces the patient's ability to recall events that occurred before, or during surgery. An oral formulation of VERSED called VERSED SYRUP(R) was approved by the FDA in October 1998. VERSED SYRUP is the only palatable, non-narcotic, short-acting oral sedative available for children. Important safety information and dosing considerations: VERSED SYRUP has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. VERSED SYRUP has been associated with reports of respiratory depression, airway obstruction, desaturation, hypoxia, and apnea, most often when used concomitantly with other central nervous system depressants (e.g., opioids). When VERSED SYRUP is given as the sole agent at recommended dosages, these adverse respiratory events occur infrequently. VERSED SYRUP should be used only in hospital or ambulatory care settings (including physicians' and dentists' offices) that can provide for continuous monitoring of respiratory and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for ventilation and intubation, and personnel trained in their use and skilled in airway management, should be assured. For deeply sedated patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. VERSED SYRUP should only be used with itraconazole or ketoconazole if absolutely necessary due to the potential for intense and prolonged sedation as well as respiratory depression. VERSED SYRUP should be used with caution in conjunction with any medications known to inhibit or induce the cytochrome P450 3A4 enzyme system. The dose of VERSED SYRUP in pediatric patients is based on body weight and must be individualized. When used in high risk patients, or in conjunction with narcotics or other CNS depressants, the minimum effective dose should be considered. VERSED SYRUP must be given only to patients if they will be monitored by direct visual observation by a health care professional. About Hoffmann-La Roche, Inc. Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures, and markets numerous important prescription drugs that improve, prolong, and save the lives of patients with serious illnesses. Among the company's areas of therapeutic interest are: Virology, including HIV/AIDS and hepatitis C; Infectious Diseases, including influenza; Cardiology; Neurology; Oncology; Transplantation; Dermatology; and Metabolic Diseases, including obesity and diabetes. The company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. For more information on Roche Pharmaceuticals in the United States, visit the company's web site at: http://www.rocheusa.com. CONTACT: Charles Alfaro of Public Affairs of Hoffmann-La Roche, Inc., 973-562-2212 or Charles.Alfaro@roche.com; or Justine O'Malley of Edelman Healthcare, 212-704-4433 or Justine_Omalley@edelman.com, for Hoffmann-La Roche, Inc. |
