Oral transmucosal fentanyl citrate for premedication in adults.
This study was designed to assess the efficacy of oral transmucosal fentanyl citrate (OTFC) for premedication in an adult population and to determine its effects on anxiety, sedation, gastric volume, and gastric fluid acidity. The fentanyl citrate is incorporated in a lozenge mounted on a handle (oralet). The effects of OTFC, placebo oralet, and no premedication were compared in a prospective, double-blind study on 90 adult ASA physical status I and II patients undergoing same-day admission surgery. Patients were randomly assigned to one of three groups: OTFC group (n = 30), placebo group (n = 30), and control group (n = 30). Arterial blood pressure, heart rate, respiratory frequency, and oxygen saturation determined by pulse oximetry were recorded before any premedication was given, and then every 10 min until the patient was taken to the operating room. Baseline anxiety and sedation levels were assessed to ensure group similarity immediately before premedication was given and at the more anxiety-provoking phase upon entering the operating room. Anxiety levels were rated using the Spielberger State-Trait Anxiety Inventory short form and sedation levels were assessed with the Ramsay scale. Side effects, as reported by the patients, were also recorded. Gastric contents were aspirated via an orogastric tube after induction of anesthesia and were measured for volume and pH. No significant differences were found among the three groups in mean arterial pressure, heart rate, or respiratory frequency. Initial oxygen saturation levels in all groups decreased after 30 min but not less than 96% except for one patient in the OTFC group, who decreased to 88%. On entering the operating room, the OTFC group demonstrated significantly higher levels of anxiolysis than the control group, but no significant differences were seen between the OTFC and the placebo groups or the placebo and control groups. Mean gastric volumes (OTFC, 29 mL; placebo, 26 mL; control, 24 mL) and pH (OTFC, 2.0; placebo, 1.8; control, 2.1) were similar in all groups. There were no significant differences among the groups in levels of sedation achieved. Mild dizziness or light-headedness was the most commonly reported side effect in 23% of the OTFC group. In the OTFC group, 71.4% like the premedicant effect as compared to 46.4% of the placebo group. Most of the groups found the oralet method of premedicant delivery very acceptable. This study demonstrates that the OTFC oralet is an effective anxiolytic in adults. It has minimal side effects and is prepared in an acceptable format. There was no measurable increase in gastric contents or acidity in the oralet groups, compared to those patients who were given nothing by mouth.
Macaluso
A D
AD
Department of Anesthesiology, Baylor University Medical Center, Dallas, TX 75246, USA.
Connelly
A M
AM
Hayes
W B
WB
Holub
M C
MC
Ramsay
M A
MA
Suit
C T
CT
Hein
H A
HA
Swygert
T H
TH
D000284:Administration, Oral; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001007:Anxiety / Q000188:drug therapy; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005744:Gastric Acid / Q000378:metabolism; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006863:Hydrogen-Ion Concentration; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000378:metabolism*; D011446:Prospective Studies; D013270:Stomach / Q000187:drug effects
D000701:Analgesics, Opioid; D006993:Hypnotics and Sedatives; D005283:Fentanyl