Oral transmucosal fentanyl citrate as an additional premedicant for adult cardiac surgery patients

Objective: To investigate the efficacy of a combination of midazolam and oral transmucosal fentanyl citrate (OTFC) as a preoperative medication for adult cardiac surgery patients compared with the use of midazolam alone. Design: A randomized, prospective study. Setting: University teaching hospital. Participants: Patients scheduled for elective coronary artery bypass surgery. Interventions: All patients were given 50 mu g/kg of midazolam intramuscularly in their rooms. Group I received 300 mu g of OTFC Oralet (Anesta Corp, Salt Lake City, UT) if they weighed less than 70 kg and 400 mu g of OTFC Oralet if they weighed more than 70 kg. Group II received a placebo Oralet. A radial artery catheter, two internal jugular venous catheters, and a pulmonary artery catheter inserted through one of the internal jugular catheters were placed in each study patient. Fentanyl was administered intravenously as a rescue drug. Measurements and Main Results: Ninety percent of midazolam/OTFC patients reported feeling no pain during catheter placement, compared with 50% of midazolam/placebo patients. Fifty percent of the placebo group required fentanyl supplement of 50 mu g intravenously because of complaints of pain, compared with 10% of the OTFC group. The midazolam/OTFC group scored approximately 20% better than the placebo group in the independent observer score of patient analgesia and the anesthesiologist rating for ease of invasive catheter placement. No myocardial ischemic events were noted in either group as determined by electrocardiogram. All patients found the Oralet mode of delivery very acceptable. Conclusions: The OTFC Oralet provides effective analgesia and sedation when combined with midazolam for invasive catheter placement in adult cardiac surgery patients. The OTFC Oralet with its gradual onset lessens the possibility of overmedicating with fentanyl, and it offers a very acceptable mode of delivery for a preemptive analgesic. Copyright (C) 1997 by W.B. Saunders Company.