Study Finds IV Sedation to be Safe and Effective in Dental Outpatients
PITTSBURGH, August 9, 2001 — Four intravenous sedation regimens have been proven safe and effective in easing pain, fear and anxiety in dental outpatients, according to a study released in the June edition of the Journal of the American Dental Association (JADA). The study was the largest prospective clinical study to evaluate the efficacy and safety of parenteral sedation.
Fear of dentistry is a significant impediment to care for a large segment of the population, despite the decrease in dental disease and improvements in pain control. According to Paul A. Moore, D.M.D., Ph.D., M.P.H., of the University of Pittsburgh School of Dental Medicine, and an author of the study, managing this fear is a primary concern of dental and medical practitioners. Intravenous conscious sedation is frequently used in medicine and dentistry to relieve patient fears during outpatient surgery.
“This study should be a reassurance to those who are scared of the dentist. Not only can we perform procedures with minimal pain, but we can also ease a patient’s fear and anxiety, making the experience less traumatic for the patient,” said Dr. Moore, who is a professor of pharmacology in the department of public health dentistry at the University of Pittsburgh School of Dental Medicine.
The collaborative, multi-center study, conducted by the Collaborative Sedations Study Group, evaluated 997 outpatients who underwent removal of impacted third molars. Patients received one of five treatments: midazolam administered to a clinical endpoint of conscious sedation; midazolam plus additional midazolam as needed during the procedure; fentanyl plus midazolam; a combination of fentanyl, midazolam and methohexital as needed during the procedure; or placebo.
Patients in all four treatment groups reported significantly less anxiety than those in the placebo group during the procedure; those on placebo reported that they felt tense and upset. Overall results were the best in the fentanyl, midazolam and methohexital treatment, significantly reducing pain and anxiety while improving efficacy of sedation.
No patients experienced significant side effects. Adverse events that were reported were consistent with sedatives and minor surgical procedures, such as drowsiness, disorientation and nausea.
The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), a division of the National Institutes of Health (NIH).
In addition to Dr. Moore, Richard Finder, D.M.D., M.S., and Douglass Jackson, D.D.S., Ph.D., participated in the University of Pittsburgh School of Dental Medicine arm of the study.
In addition to the University of Pittsburgh, the investigation was conducted at the University of California Los Angeles School of Dentistry, University of Kentucky School of Dentistry, University of North Carolina School of Dentistry and University of Washington.