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Theodore H. Stanley - One of the best experts on this subject based on the ideXlab platform.
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Oral transmucosal Fentanyl Citrate (OTFC) for the treatment of postoperative pain.
Anesthesia and analgesia, 1993Co-Authors: Michael A. Ashburn, Nathan L. Pace, G. H. Lind, M. H. Gillie, A. J. F. De Boer, Theodore H. StanleyAbstract: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.(ABSTRACT TRUNCATED AT 250 WORDS)
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Absorption and Bioavailability of Oral Transmucosal Fentanyl Citrate
Anesthesiology, 1991Co-Authors: James B. Streisand, John R. Varvel, Donald R. Stanski, Leon Le Maire, Michael A. Ashburn, Brian Hague, Stephen D. Tarver, Theodore H. StanleyAbstract: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).(ABSTRACT TRUNCATED AT 250 WORDS)
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absorption and bioavailability of oral transmucosal Fentanyl Citrate
Anesthesiology, 1991Co-Authors: James B. Streisand, John R. Varvel, Donald R. Stanski, Michael A. Ashburn, Brian Hague, Stephen D. Tarver, Leon Le Maire, Theodore H. StanleyAbstract: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 μg/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 1/min; volume of distribution at steady state was 287 ± 79 1; 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 μg/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 μg/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). Terminal elimination half-life was similar after all modes of Fentanyl delivery–OTFC (460 ± 313 min), iv (425 ± 102 min), or oral solution (469 ± 123 min). These results suggest that although absorption of Fentanyl from OTFC occurs through both the oral mucosa and the gastrointestinal tract, it is more rapid at the former. The data also indicate that sequestration of Fentanyl in the oral mucosa is minimal.
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Oral transmucosal Fentanyl Citrate for analgesia and sedation in the emergency department.
Annals of emergency medicine, 1991Co-Authors: G. H. Lind, Michael A. Ashburn, M. A. E. Marcus, S. L. Mears, Brian J. Peterson, Kurt T Bernhisel, Theodore H. StanleyAbstract:Study objective: To evaluate the safety and efficacy of oral transmucosal Fentanyl Citrate (OTFC) as a noninvasive method of providing analgesia and sedation for patients in the emergency department. Design: Prospective, nonblinded. Setting: ED of a tertiary care university hospital. Type of participants: Ten patients, 6 to 34 years old, with acute painful conditions requiring treatment in the ED. Interventions: Premedication with OTFC and local anesthetic prior to incision or wound closure. Measurements and main results: Pain and activity (sedation) scores, vital signs (including systolic and diastolic arterial blood pressures, heart and respiratory rates, and pulse oximetry-determined oxygen saturation) were measured before and at two- to ten-minute intervals during and after OTFC consumption. All patients accepted OTFC. Patients received an average of 13.7 ± 2.5 μ g/kg of Fentanyl Citrate in 11.8 ± 6.8 minutes. Decreases in pain were reported in two patients in two minutes and by all patients 14 minutes after beginning OTFC consumption. Sixty percent of patients became drowsy or sedated 12 to 30 minutes after beginning OTFC. Vital signs and oxygen saturation changes were small and not clinically significant. The most important side effects were pruritus (30%), nausea (20%), and dizziness and dry mouth (40%). All were considered mild and not disturbing, although one patient required post-procedure antiemetic therapy for recurrent vomiting. The mean time to discharge from the ED was 139 ± 54 minutes after receiving OTFC. Conclusion: OTFC may be useful in providing rapid, noninvasive analgesia and sedation in the ED and deserves further evaluation.
James B. Streisand - One of the best experts on this subject based on the ideXlab platform.
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Dose proportionality and pharmacokinetics of oral transmucosal Fentanyl Citrate.
Anesthesiology, 1998Co-Authors: James B. Streisand, Michael A. Busch, Talmage D. Egan, Barbara Gaylord Smith, Nathan L. PaceAbstract:BackgroundThe pharmacokinetics of a single dose (15 micro gram/kg) of oral transmucosal Fentanyl Citrate (OTFC) have been characterized. A range of doses may eventually be used in clinical practice. The goal of this study was to determine if the pharmacokinetics of OTFC are dose proportional for dos
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A review of oral transmucosal Fentanyl Citrate: potent, rapid and noninvasive opioid analgesia.
Journal of palliative medicine, 1998Co-Authors: Perry G. Fine, James B. StreisandAbstract:The physiochemical characteristics of the potent synthetic opioid agonist Fentanyl make it ideal for noninvasive transmucosal delivery. Studies of oral transmucosal Fentanyl Citrate (OTFC), a candied matrix formulation administered orally as a palatable lozenge on a stick, have investigated and determined this analgesic's pharmacokinetics and pharmacodynamics in a number of clinical settings, including premedication before surgery, acute analgesia for painful medical procedures, and, most recently, for the control of breakthrough cancer pain. The onset to meaningful pain relief in patients with acute pain from surgery or breakthrough pain from cancer is between 5 and 10 minutes after initiating OTFC use, equivalent to intravenous morphine. Analgesic dose equivalency studies suggest that OTFC is, on average, about 10 times more potent than morphine, although, in randomized, controlled, and blinded studies, many patients who were using relatively high doses of opioid anlagesics on an aroundthe- clock schedu...
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Oral transmucosal Fentanyl Citrate premedication in patients undergoing outpatient dermatologic procedures.
The Journal of dermatologic surgery and oncology, 1994Co-Authors: John W. Gerwels, Leon Le Maire, John L. Bezzant, Lynne F. Pauley, James B. StreisandAbstract:background. Oral transmucosal Fentanyl Citrate (OTFC) is a novel lozenge dosage form of Fentanyl used for premedication. Many dermatology patients undergoing surgical procedures could benefit from such a medication. objective. The study compared the safety and efficacy of 400- vs 800- μg dosage forms for their sedative and anxiolytic effects in adults undergoing a variety of dermatologic outpatient surgical procedures. methods. Patients received OTFC 30 minutes before the procedura. Vital signs, oxygen Saturation, sedation, and anxiety scores were measured before OTFC administration and every 15 minutes thereafter. results. Significant sedation and anxiolysis developed in both dosage groups. No clinically significant changes in respiratory rate, heart rate, or blood pressure occurred during the study period. Common drug-induced side effects included dizziness, nausea, pruritus, and vomiting. conclusion. OTFC is safe and effective for outpatient dermatologic procedures; however, the risk of opioid-related side effects must be carefully weighed against the benefits when deciding to use OTFC in an outpatient setting.
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Absorption and Bioavailability of Oral Transmucosal Fentanyl Citrate
Anesthesiology, 1991Co-Authors: James B. Streisand, John R. Varvel, Donald R. Stanski, Leon Le Maire, Michael A. Ashburn, Brian Hague, Stephen D. Tarver, Theodore H. StanleyAbstract: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).(ABSTRACT TRUNCATED AT 250 WORDS)
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absorption and bioavailability of oral transmucosal Fentanyl Citrate
Anesthesiology, 1991Co-Authors: James B. Streisand, John R. Varvel, Donald R. Stanski, Michael A. Ashburn, Brian Hague, Stephen D. Tarver, Leon Le Maire, Theodore H. StanleyAbstract: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 μg/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 1/min; volume of distribution at steady state was 287 ± 79 1; 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 μg/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 μg/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). Terminal elimination half-life was similar after all modes of Fentanyl delivery–OTFC (460 ± 313 min), iv (425 ± 102 min), or oral solution (469 ± 123 min). These results suggest that although absorption of Fentanyl from OTFC occurs through both the oral mucosa and the gastrointestinal tract, it is more rapid at the former. The data also indicate that sequestration of Fentanyl in the oral mucosa is minimal.
Joan Burg - One of the best experts on this subject based on the ideXlab platform.
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Comparison of Oral Transmucosal Fentanyl Citrate and Intramuscular Meperidine, Promethazine, and Chlorpromazine for Conscious Sedation of Children Undergoing Laceration Repair
Annals of emergency medicine, 1996Co-Authors: Sara A. Schutzman, Erica Liebelt, Mary Wisk, Joan BurgAbstract:Abstract Study objective: To compare oral transmucosal Fentanyl Citrate (OTFC) with IM meperidine, promethazine, and chlorpromazine (MPC) for conscious sedation of children. Methods: This prospective, randomized, single-blinded study involved a convenience sample of 40 children, 3 to 8 years of age, who presented to an urban pediatric emergency department and required laceration repair. Patients were premedicated with either OTFC (10 to 15 μg/kg) and a mock injection or intramuscular MPC (2 mg/kg meperidine, .5 mg/kg promethazine, and .5 mg/kg chlorpromazine) followed by a placebo lozenge. Results: Both OTFC and MPC caused significant reductions in activity scores at 15 to 75 minutes after medication administration. Although the MPC group was more sedated, there was no difference between groups in Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores during the laceration repair or in the suturing physician's assessment of sedation quality (rated excellent or good for 75% and 69% of OTFC and MPC groups, respectively). Two children (both in the OTFC group) had oxygen saturation levels of less than 95% but required only transient supplemental oxygen. Other adverse events were common but not serious; they differed between groups in type but not number, with vomiting in 45% of the OTFC group and prolonged somnolence in 37% of the MPC group. Mean time to discharge was 99 minutes, with no difference between groups. Conclusions: Both medications reduced activity significantly. Although MPC caused deeper sedation, the medications had comparable effects on patient behavior during the repair and yielded comparable ratings of physician satisfaction. Large numbers of nonserious adverse events occurred in both groups. [Schutzman SA, Liebelt E, Wisk M, Burg J: Comparison of oral transmucosal Fentanyl Citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair. Ann Emerg Med October 1996;28:385-390.]
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Oral transmucosal Fentanyl Citrate for premedication of children undergoing laceration repair
Annals of emergency medicine, 1994Co-Authors: Sara A. Schutzman, Joan Burg, Erica Liebelt, Maureen Strafford, Neil L. Schechter, Mary Wisk, Gary R. FleisherAbstract:Study objective: To evaluate the safety and efficacy of twodoses of oral transmucosal Fentanyl Citrate (OTFC) for premedication of children undergoing laceration repair. Design: Prospective, randomized, nonblinded study. Setting: Urban pediatric emergency department. Participants: Thirty children aged 2 to 8 years requiring laceration repair. Interventions: Premedication with either 10 to 15 μg/kg or 15to 20 μg/kg of OTFC. Results: Activity score, vital signs, oxygen saturation, and painscores were recorded before and after administration of OTFC. Activity scores decreased significantly 15 to 60 minutes after OTFC. The physician suturing the wound rated the child's sedation/pain control as excellent or good in 83% of patients. Vital signs changes were not clinically remarkable. Oxygen saturations remained at 95% or more except in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dose group and 47% of the higher-dose group. There were no significant differences between dose groups for activity or pain score changes, physician assessment, discharge times, or adverse events. Conclusion: Both doses of OTFC reduced activity with comparableefficacy, with no serious vital signs changes. However, the higher-dose group had a greater number ( P =NS) of adverse effects.
J Spoorenberg - One of the best experts on this subject based on the ideXlab platform.
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xylazine and a xylazine Fentanyl Citrate azaperone combination in farmed deer ii velvet antler removal and reversal combinations
New Zealand Veterinary Journal, 1996Co-Authors: P R Wilso, K J Stafford, J Iemans, Clare J Veltma, J SpoorenbergAbstract:Three studies were undertaken on farmed red and red x wapiti deer to evaluate xylazine and a xylazine/Fentanyl Citrate/azaperone combination for velvet antler removal. In the first experiment, 30 1-2 year-old red and 25% red x wapiti deer whose velvet was to be removed were given either 5% xylazine alone at 0.5 mg/kg body weight intramuscularly or the same dose rate of a commercially available mixture of 5% xylazine with the addition of 0.4 mg of Fentanyl Citrate and 3.2 mg of azaperone per ml. Physiological, behavioural and analgesic responses and reversal times after yohimbine or yohimbine and naloxone were monitored. There were no differences in heart rate, respiration rate, sedative or analgesic properties detected between xylazine or the xylazine/Fentanyl Citrate/azaperone combination. All deer became recumbent, but those given the xylazine/Fentanyl Citrate/azaperone combination became recumbent more rapidly than those given xylazine alone (9.4 and 12.5 minutes, respectively, p<0.05). The arousal pattern and timing of reversal of xylazine and xylazine/Fentanyl Citrate/azaperone using yohimbine and yohimbine and naloxone, respectively, were similar. The second experiment evaluated the reversal of the xylazine/Fentanyl Citrate/azaperone combination with either yohimbine or yohimbine and naloxone in 43 3-year-old red deer stags after velvet antler removal. There were no differences in arousal pattern or time to standing between reversal treatments. Sixteen 1-year-old red and 25% red x wapiti stags were used in the third experiment to evaluate clinically the analgesic properties of xylazine and xylazine/Fentanyl Citrate/azaperone combination during velvet removal without the application of a local anaesthetic agent. Withdrawal responses were observed in most deer after the xylazine/Fentanyl Citrate/azaperone combination at dosages containing 0.5, 0.7 and 0.75 mg of xylazine/kg and after xylazine alone at 0.7 mg/kg, indicating that insufficient analgesia was provided by the systemic agent for the surgical procedure of velvet antler removal. These studies have shown that the knock-down effect of the xylazine/Fentanyl Citrate/azaperone combination was more rapid than that of xylazine alone, but that other physiological, behavioural and analgesic responses at doses used and evaluated by the methods used were similar. Reversal of both the xylazine and xylazine/Fentanyl Citrate/azaperone combination was similar when using either yohimbine alone for xylazine and the xylazine/Fentanyl Citrate/azaperone combination or yohimbine and naloxone for the xylazine/Fentanyl Citrate/azaperone combination. The evaluation of surgical analgesia for antler removal suggested that both xylazine alone and the xylazine/Fentanyl Citrate/azaperone combination provided insufficient analgesia and that local anaesthetic should be used in all cases.
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xylazine and a xylazine Fentanyl Citrate azaperone combination in farmed deer i dose rate comparison
New Zealand Veterinary Journal, 1996Co-Authors: Peter R. Wilson, K J Stafford, Clare J. Veltman, J. Beimans, J SpoorenbergAbstract:Abstract Six 1-year-old farmed red deer were used to compare physiological and behavioural responses to a range of doses of 5% xylazine with or without the addition of 0.4 mg of Fentanyl Citrate and 3.2 mg of azaperone per ml. Each deer was randomly assigned to one of six treatments: xylazine alone at 0.4 and 0.6 mg/kg, the xylazine/Fentanyl Citrate/azaperone combination containing 0.2, 0.4 and 0.6 mg/kg of xylazine, or a sterile water control. Injections were given intramuscularly in the anterior neck, operator blind, on each of 6 sampling days between October and January, such that each deer received all treatments with 9–28 days between each treatment. Measurements included heart rate and respiration rate. A 0–3 scoring system (normal to nil response, respectively) was devised to record sedative responses (body stance, head position, degree of eye closure, palpebral reflex, resistance to movement of the head, response to noise) and analgesic responses to touch and pinching of the ear, and response to a...
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Xylazine and a xylazine/Fentanyl Citrate/azaperone combination in farmed deer. II: velvet antler removal and reversal combinations.
New Zealand veterinary journal, 1996Co-Authors: Peter R. Wilson, K J Stafford, J. Biemans, Clare J. Veltman, J SpoorenbergAbstract:Three studies were undertaken on farmed red and red x wapiti deer to evaluate xylazine and a xylazine/Fentanyl Citrate/azaperone combination for velvet antler removal. In the first experiment, 30 1-2 year-old red and 25% red x wapiti deer whose velvet was to be removed were given either 5% xylazine alone at 0.5 mg/kg body weight intramuscularly or the same dose rate of a commercially available mixture of 5% xylazine with the addition of 0.4 mg of Fentanyl Citrate and 3.2 mg of azaperone per ml. Physiological, behavioural and analgesic responses and reversal times after yohimbine or yohimbine and naloxone were monitored. There were no differences in heart rate, respiration rate, sedative or analgesic properties detected between xylazine or the xylazine/Fentanyl Citrate/azaperone combination. All deer became recumbent, but those given the xylazine/Fentanyl Citrate/azaperone combination became recumbent more rapidly than those given xylazine alone (9.4 and 12.5 minutes, respectively, p
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Xylazine and a xylazine/Fentanyl Citrate/azaperone combination in farmed deer. I: dose rate comparison.
New Zealand veterinary journal, 1996Co-Authors: Peter R. Wilson, K J Stafford, Clare J. Veltman, J. Beimans, J SpoorenbergAbstract:Abstract Six 1-year-old farmed red deer were used to compare physiological and behavioural responses to a range of doses of 5% xylazine with or without the addition of 0.4 mg of Fentanyl Citrate and 3.2 mg of azaperone per ml. Each deer was randomly assigned to one of six treatments: xylazine alone at 0.4 and 0.6 mg/kg, the xylazine/Fentanyl Citrate/azaperone combination containing 0.2, 0.4 and 0.6 mg/kg of xylazine, or a sterile water control. Injections were given intramuscularly in the anterior neck, operator blind, on each of 6 sampling days between October and January, such that each deer received all treatments with 9–28 days between each treatment. Measurements included heart rate and respiration rate. A 0–3 scoring system (normal to nil response, respectively) was devised to record sedative responses (body stance, head position, degree of eye closure, palpebral reflex, resistance to movement of the head, response to noise) and analgesic responses to touch and pinching of the ear, and response to a...
Sara A. Schutzman - One of the best experts on this subject based on the ideXlab platform.
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Comparison of Oral Transmucosal Fentanyl Citrate and Intramuscular Meperidine, Promethazine, and Chlorpromazine for Conscious Sedation of Children Undergoing Laceration Repair
Annals of emergency medicine, 1996Co-Authors: Sara A. Schutzman, Erica Liebelt, Mary Wisk, Joan BurgAbstract:Abstract Study objective: To compare oral transmucosal Fentanyl Citrate (OTFC) with IM meperidine, promethazine, and chlorpromazine (MPC) for conscious sedation of children. Methods: This prospective, randomized, single-blinded study involved a convenience sample of 40 children, 3 to 8 years of age, who presented to an urban pediatric emergency department and required laceration repair. Patients were premedicated with either OTFC (10 to 15 μg/kg) and a mock injection or intramuscular MPC (2 mg/kg meperidine, .5 mg/kg promethazine, and .5 mg/kg chlorpromazine) followed by a placebo lozenge. Results: Both OTFC and MPC caused significant reductions in activity scores at 15 to 75 minutes after medication administration. Although the MPC group was more sedated, there was no difference between groups in Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores during the laceration repair or in the suturing physician's assessment of sedation quality (rated excellent or good for 75% and 69% of OTFC and MPC groups, respectively). Two children (both in the OTFC group) had oxygen saturation levels of less than 95% but required only transient supplemental oxygen. Other adverse events were common but not serious; they differed between groups in type but not number, with vomiting in 45% of the OTFC group and prolonged somnolence in 37% of the MPC group. Mean time to discharge was 99 minutes, with no difference between groups. Conclusions: Both medications reduced activity significantly. Although MPC caused deeper sedation, the medications had comparable effects on patient behavior during the repair and yielded comparable ratings of physician satisfaction. Large numbers of nonserious adverse events occurred in both groups. [Schutzman SA, Liebelt E, Wisk M, Burg J: Comparison of oral transmucosal Fentanyl Citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair. Ann Emerg Med October 1996;28:385-390.]
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Oral transmucosal Fentanyl Citrate for premedication of children undergoing laceration repair
Annals of emergency medicine, 1994Co-Authors: Sara A. Schutzman, Joan Burg, Erica Liebelt, Maureen Strafford, Neil L. Schechter, Mary Wisk, Gary R. FleisherAbstract:Study objective: To evaluate the safety and efficacy of twodoses of oral transmucosal Fentanyl Citrate (OTFC) for premedication of children undergoing laceration repair. Design: Prospective, randomized, nonblinded study. Setting: Urban pediatric emergency department. Participants: Thirty children aged 2 to 8 years requiring laceration repair. Interventions: Premedication with either 10 to 15 μg/kg or 15to 20 μg/kg of OTFC. Results: Activity score, vital signs, oxygen saturation, and painscores were recorded before and after administration of OTFC. Activity scores decreased significantly 15 to 60 minutes after OTFC. The physician suturing the wound rated the child's sedation/pain control as excellent or good in 83% of patients. Vital signs changes were not clinically remarkable. Oxygen saturations remained at 95% or more except in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dose group and 47% of the higher-dose group. There were no significant differences between dose groups for activity or pain score changes, physician assessment, discharge times, or adverse events. Conclusion: Both doses of OTFC reduced activity with comparableefficacy, with no serious vital signs changes. However, the higher-dose group had a greater number ( P =NS) of adverse effects.