ORAL TRANSMUCOSAL FENTANYL CITRATE AS AN ADDITIONAL PREMEDICANT FOR ADULT CARDIAC-SURGERY PATIENTS

Objective: To investigate the efficacy of a combination of midazolam a nd oral transmucosal fentanyl citrate (OTFC) as a preoperative medicat ion for adult cardiac surgery patients compared with the use of midazo lam alone. Design: A randomized, prospective study. Setting: Universit y teaching hospital. Participants: Patients scheduled for elective cor onary 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 wei ghed 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 cathet er, two internal jugular venous catheters, and a pulmonary artery cath eter inserted through one of the internal jugular catheters were place d in each study patient. Fentanyl was administered intravenously as a rescue drug. Measurements and Main Results: Ninety percent of midazola m/OTFC patients reported feeling no pain during catheter placement, co mpared with 50% of midazolam/placebo patients. Fifty percent of the pl acebo group required fentanyl supplement of 50 mu g intravenously beca use of complaints of pain, compared with 10% of the OTFC group. The mi dazolam/OTFC group scored approximately 20% better than the placebo gr oup in the independent observer score of patient analgesia and the ane sthesiologist rating for ease of invasive catheter placement. No myoca rdial ischemic events were noted in either group as determined by elec trocardiogram. All patients found the Oralet mode of delivery very acc eptable. 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 o nset lessens the possibility of overmedicating with fentanyl, and it o ffers a very acceptable mode of delivery for a preemptive analgesic. C opyright (C) 1997 by W.B. Saunders Company.