Fentanyl Lollipop


Pediatrics 1995 Mar;95(3):335-339

The use of oral transmucosal fentanyl citrate for painful procedures in children.

Schechter NL, Weisman SJ, Rosenblum M, Bernstein B, Conard PL

Department of Pediatrics, Saint Francis Hospital and Medical Center, Hartford, CT 06105.

OBJECTIVE. To investigate the efficacy and safety of oral transmucosal fentanyl (OTFC) in providing analgesia and sedation for painful diagnostic procedures in children. DESIGN. Randomized, placebo-controlled clinical trial. METHOD. Forty-eight children referred to the University Connecticut Division of Pediatric Hematology/Oncology for bone marrow aspiration or lumbar puncture were randomized to receive either OTFC (15 to 20 micrograms/kg) or a placebo lollipop. Thirty minutes after administration, the procedure was begun. An anesthesiologist monitored the child's heart rate, blood pressure, and oxygen saturation every 10 minutes. At the conclusion of the procedure, the nurse, the child's parent, and all children over 8 years of age were asked to rate the pain associated with the procedure using a 1 to 10 visual analogue scale. Young children (less than 8) used a modified scale, the Oucher, yielding a 0 to 5 score. RESULTS. Significant differences in pain ratings between the OTFC and placebo groups were noted on the pain scores of the parents (P = .005), nurses (P = .001), younger children (P = .006), and older children (P = .013), and median pain scores in the OTFC group were reduced to tolerable levels. Vomiting (P = .003) and itching (P = .001) were more common in the OTFC group, but no clinically significant vital sign deviations occurred. CONCLUSION. OTFC is safe and effective for use in relieving the pain of pediatric procedures, but frequency of vomiting may restrict its clinical usefulness.


Anesth Analg 1996 Dec;83(6):1200-1205

The safety and efficacy of oral transmucosal fentanyl citrate for preoperative sedation in young children.

Epstein RH, Mendel HG, Witkowski TA, Waters R, Guarniari KM, Marr AT, Lessin JB

Department of Anesthesiology, Jefferson Medical College, Philadelphia, Pennsylvania 19107, USA.

Oral transmucosal fentanyl citrate (OTFC) is a labeled preoperative pediatric sedative. Doses greater than 15 micrograms/kg are associated with a high incidence of post-operative nausea and vomiting and occasional respiratory depression. We studied the safety and efficacy of OTFC in children 6 yr old and younger at a dose of 15 micrograms/kg. Nineteen patients undergoing surgery associated with postoperative pain were randomized to receive OTFC/intravenous (IV) saline or placebo lozenge/IV fentanyl. After 45 min, patients receiving OTFC became more sedated than the placebo group, but there were no differences in cooperation, apprehension, parental separation, or induction cooperation scores. Preoperatively, neither respiratory depression nor oxygen desaturation occurred. Nine of 10 OTFC patients developed mild pruritus, and three of 10 OTFC patients vomited preoperatively; neither complication occurred in the placebo group. (The high incidence of preoperative vomiting led to the termination of the protocol before the anticipated enrollment of 40 patients.) General anesthesia was induced via a mask, followed by a propofol infusion. Spo2 and respiratory rate were monitored, and sedation, apprehension, cooperation, ease of parental separation, and induction cooperation were scored. One OTFC patient developed rigidity during induction. Emergence and recovery were not delayed by OTFC despite a 50% incidence of postoperative vomiting. We do not recommend the use of OTFC in a 15 micrograms/kg dose as a routine preoperative sedative in children 6 yr old and younger.


Pain 1991 May;45(2):149-153

An open label study of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain.

Fine PG, Marcus M, De Boer AJ, Van der Oord B

Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City 84132.

Ten patients with advanced cancer and breakthrough pain between the ages of 39 and 78 received oral transmucosal fentanyl citrate (10-15 micrograms/kg) 4 or 5 times each over 2 days (42 total administrations) in an open study. Baseline vital sign and rating scale results did not vary over administrations, except for heart rate which showed an 8 beats/min decrease over 4 administrations. Heart rate and oxygen saturation did not vary significantly over 120 min of evaluation, and minimal changes in blood pressure and respiration rate were found. Significant reduction in pain scores as measured by a pain descriptive scale, the McGill-Melzack scale, and a numeric (VAS) scale were seen at all evaluations from 5 to 120 min. Average time to onset of pain relief was 9.5 min after administration. Wellbeing was significantly increased at all evaluations. Activity level as recorded by the investigator was significantly reduced from 10 to 30 min after administration, however, activity level as reported by the patient was significantly increased at 5 min and from 60 to 120 min after OTFC administration. There were no significant adverse effects.


Anesth Analg 1993 Feb;76(2):377-381

Oral transmucosal fentanyl citrate (OTFC) for the treatment of postoperative pain.

Ashburn MA, Lind GH, Gillie MH, de Boer AJ, Pace NL, Stanley TH

Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City 84132.

Oral transmucosal fentanyl citrate (OTFC) has been used in a variety of clinical situations. This study was designed to determine if OTFC could provide analgesia to patients with acute pain after major surgery. Following written informed consent, 38 ASA Physical Status I-III patients undergoing either a total hip replacement or total knee arthroplasty were studied prospectively. The patients were randomly allocated to receive either OTFC (7-10 micrograms/kg) or a placebo identical in appearance to an OTFC unit. General anesthesia was administered for surgery, and patient-controlled analgesia (PCA) with morphine was initiated in all patients. The PCA interval dose was adjusted to provide adequate analgesia as determined by the patient and physician; the PCA lock-out time was not changed. On the morning after surgery, the most recent 12 h of PCA data (milligrams per hour of morphine and PCA attempts per hour) were recorded. OTFC or placebo units were administered at times 0, 4, and 8 h during a 12-h study, resulting in three identical units being completely consumed. PCA data, as well as incidence and severity of any adverse side effects, were recorded during the study and for the next 12 h. Treatment groups were compared for similarity, and study variables were analyzed. Twenty-eight patients completed the study, 13 in the control group and 15 in the OTFC group. There were no significant differences between the study groups as to patients' age, gender, ASA classification, or surgical procedure. In addition, there were no differences between the groups in the number of PCA attempts or delivered dose of morphine during the prestudy or poststudy periods.


Anesthesiology 1991 Aug;75(2):223-229

Absorption and bioavailability of oral transmucosal fentanyl citrate.

Streisand JB, Varvel JR, Stanski DR, Le Maire L, Ashburn MA, Hague BI, Tarver SD, Stanley TH

Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City 84132.

Oral transmucosal fentanyl citrate (OTFC) is a novel, noninvasive dosage form of fentanyl used to provide children and adults with sedation, anxiolysis, and analgesia. In order to determine the bioavailability and absorption of fentanyl from OTFC, 12 volunteers were given intravenous fentanyl citrate or OTFC 15 micrograms/kg on each of two occasions. On a third occasion, the authors assessed oral administration (gastrointestinal absorption) by giving eight of the same volunteers the same dose of a solution of fentanyl citrate to swallow. In each study, arterial blood samples were taken over 24 h for analysis of plasma fentanyl. After intravenous (iv) administration of fentanyl, clearance (mean +/- standard deviation) was 0.67 +/- 0.15 l/min; volume of distribution at steady state was 287 +/- 79 l; and the terminal elimination half-life was 425 +/- 102 min. Peak plasma concentrations of fentanyl were higher (3.0 +/- 1.0 vs. 1.6 +/- 0.6 ng/ml, P = 0.01) and occurred sooner (22 +/- 2.5 vs. 101 +/- 48.8 min, P = 0.003) after OTFC than after oral solution administration. Plasma concentrations of fentanyl after OTFC decreased rapidly, to less than 1.0 ng/ml within 75-135 min after the beginning of administration. Peak absorption rate was greater (11.1 +/- 4.3 vs. 3.6 +/- 2.1 micrograms/min, P = 0.004) and occurred much sooner after OTFC than after oral solution administration (19 +/- 2.6 vs. 87.5 +/- 38.1 min, P = 0.001). Systemic bioavailability was greater after OTFC administration than after the oral solution (0.52 +/- 0.1 vs. 0.32 +/- 0.1, P = 0.01).