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PubMed1991

The effect of neuroleptanalgesia (droperiodol-fentanyl) on motor potentials evoked by transcranial magnetic stimulation in the monkey.

Motor evoked potentials (MEPs) after transcranial magnetic stimulation (TMS) have been examined in 12 monkeys under neuroleptanalgesia (NLA). Compound muscle action potentials were recorded from abductor policis brevis (APB) and gastroncnemius (GN) muscles contralateral to the stimulation site. After obtaining baseline tracings during emergence from methohexitone, 10 mg/kg i.m., NLA was induced using droperiodol, 0.3 mg/kg i.v. followed by fentanyl, 0.006 mg/kg i.v. Sequential MEP recordings were obtained 10 min after i.v. droperiodol, 2, 8, and 16 min after i.v. fentanyl, and during recovery. Replicable TMS MEPs were consistently recorded under NLA. However, droperidol and fentanyl caused significant stimulation threshold elevation, amplitude depression, and latency delay compared to control values (p <0.01). Ten minutes after droperiodol administration, the APB-GN threshold, amplitude, and latency values (mean +/- SD) were 0.81 +/- 0.2-0.84 +/- 0.1 T (baseline 0.57 +/- 0.1-0.59 +/- 0.1 T), 3.4 +/- 2.1-4.0 +/- 2.5 mV (baseline 8.0 +/- 3.7-9.0 +/- 3.7 mV), and 15.8 +/- 1.3-21.1 +/- 1.2 ms (baseline 14.9 +/- 1.2-20.1 +/- 1.3 ms), respectively. Addition of fentanyl resulted in further response deterioration. Two minutes after fentanyl injection, the APB-GN threshold, amplitude, and latency values were 0.88 +/- 0.18-0.95 %% 0.15 T, 2.1 +/- 1.7-2.0 +/- 2.1 mV, and 16.0 +/- 1.4-21.9 +/- 1.3 ms, respectively. Subsequent MEPs revealed gradual response improvement but, in contrast to baseline, remained markedly altered (p <0.05). During the recovery period (53 +/- 6 min), the APB-GN threshold, amplitude, and latency measurements were 0.66 +/- 0.1-0.77 +/- 0.2 T, 4.4 +/- 3.1-4.2 +/- 2.9 mV, 15.5 %% 1.4-20.9 +/- 1.7 ms, respectively. We conclude that, in a primate model, NLA maintains measurable TMS MEPs. Nevertheless, droperiodol and fentanyl produce significant and prolonged response alterations. Knowledge of these changes, while administering NLA drugs intraoperatively, is essential to interpretation of MEP data.

Journal Article↗

PubMed2001

Efficacy of an enteral 10-day methadone wean to prevent opioid withdrawal in fentanyl-tolerant pediatric intensive care unit patients.

OBJECTIVE: To demonstrate the efficacy of a 10-day, single daily dose, enteral methadone weaning protocol for the prevention of opioid withdrawal symptoms in pediatric patients after prolonged fentanyl exposure. DESIGN: Prospective, observational study. SETTING: Twenty-four-bed medical-surgical intensive care unit within a 222-bed pediatric teaching hospital. PATIENTS: Twenty-nine children, aged 1 day to 19.8 yrs, who received methadone to prevent opioid withdrawal after prolonged continuous fentanyl infusion exposure. INTERVENTIONS: Institution of a standardized methadone weaning protocol. MEASUREMENTS AND MAIN RESULTS: All 29 patients had received a continuous fentanyl infusion; duration of exposure was 14.5 +/- 9.2 days, cumulative fentanyl dose was 1.93 +/- 1.53 mg/kg, and peak fentanyl infusion was 9.6 +/- 4.3 microg/kg per hr. Twenty-five (86%) of 29 patients successfully completed the methadone wean in 10 days. Withdrawal complications that required a weaning delay were seen in three patients, and one patient expired before completion. Sixteen patients were discharged to complete their weaning schedule at home without incident. CONCLUSIONS: Opioid withdrawal symptoms in pediatric intensive care unit patients after prolonged fentanyl exposure can be avoided by using an enteral, 10-day, single daily dose methadone weaning protocol.

Journal Article↗

PubMed2004

Pharmacokinetic profile and efficacy of a fentanyl transdermal delivery system for acute postoperative pain after intra-abdominal gynecologic surgery for cancer.

PURPOSE: This prospective, randomized, single-blind study evaluated the efficacy and pharmacokinetic profile of a transdermal delivery system for fentanyl to provide relief of acute postoperative pain in patients undergoing intra-abdominal gynecologic surgery for cancer. METHODS: Forty female patients were randomized to either transdermal fentanyl 50 microg/hour (n = 20) or transdermal placebo (n = 20). Transdermal systems were placed 1 hour preoperatively and removed 25 hours later. Pain control was supplemented with a nonopioid drug, bupivacaine 0.125-0.25%, administered through an epidural catheter via patient-controlled epidural analgesia. Serum fentanyl concentrations, bupivacaine consumption, pain scores [visual analog scale (VAS)], sedation rating score, adverse events, and physiological parameters were recorded for 48 hours postoperatively. RESULTS: The minimum effective concentration of fentanyl in serum (0.63 ng/mL) was achieved at 11.3 +/- 4.9 hours after application, and serum concentrations remained above this level until 13 hours after removal. The TTS-F group had lower VAS pain scores and a significant 66% reduction in utilization of bupivacaine compared with placebo. Pain scores were significantly correlated with serum fentanyl concentration (P = 0.025). All physiological parameters fluctuated within normal range and no differences were observed between treatments. Adverse events were similar between the groups with only the incidence of local erythema significantly higher in the TTS-F group (30% vs. 5%, P < 0.05), and sedation scores were significantly higher in the TTS-F group during the immediate postoperative period. CONCLUSION: The transdermal therapeutic system for administration of fentanyl, combined with epidural administration of a nonopioid analgesic such as bupivacaine is effective in controlling postoperative pain after gynecologic surgery. Additionally, the safety/tolerability of this regimen was similar to placebo plus bupivacaine.

Journal Article↗

PubMed2026

A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy.

BACKGROUND: Tonsillectomy is one of the most frequently performed pediatric surgeries; however, little evidence guides the choice of intraoperative opioids in a population at an elevated risk for perioperative respiratory complications. This study tested the hypothesis that fewer children who received hydromorphone during tonsillectomy would require postoperative "rescue" opioids compared to children who received fentanyl. METHODS: We conducted a triple-blind, randomized, controlled trial to compare intravenous hydromorphone versus fentanyl in pediatric patients undergoing tonsillectomy. Children aged 2-15 years undergoing bilateral tonsillectomy or adenotonsillectomy were assigned (1:1) to receive hydromorphone (10 mcg/kg) or fentanyl (1 mcg/kg) intraoperatively. The primary endpoint was the number of patients who required rescue intravenous opioid analgesia following endotracheal extubation. Secondary endpoints included pain scores, pulse oximetry saturations, postoperative nausea, time in the recovery room, morphine milligram equivalents in the post-anesthesia care unit, and adverse events. RESULTS: A total of 188 children underwent randomization, and 180 were analyzed (90 in each group). The median age was 5 years (interquartile range: 3-7 years). Rescue intravenous opioid was administered to 48 (53%) children who received intraoperative hydromorphone and 66 (73%) children who received intraoperative fentanyl (difference, 20.0 percentage points; 95% confidence interval, 6.2-33.8) (p = 0.005). Children who received hydromorphone also had lower mean pain scores for the first 15 min postoperatively and lower median morphine milligram equivalents. The incidence of adverse events was similar between the two groups. CONCLUSIONS: This study in children undergoing tonsillectomy found that intraoperative hydromorphone resulted in improved analgesia in the recovery room compared to fentanyl. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04230681.

Adolescent↗

PubMed1988

Delayed muscular rigidity and respiratory depression following fentanyl anesthesia.

A delayed effect of fentanyl used for anesthesia may be respiratory distress several hours after surgery. The findings are muscular rigidity, fall in chest wall compliance, hypoventilation, respiratory acidosis, and hypotension. In the past, to our knowledge, this complication was exclusively reported in patients undergoing cardiac surgery, when large fentanyl dosages are employed. This article describes three general surgical patients in whom respiratory distress developed three to five hours following colon surgery when a moderate dose of fentanyl citrate, 55 to 75 micrograms/kg, was used. Initially, all patients had a normal recovery from anesthesia. Later, respiratory distress was successfully treated with a fentanyl antagonist and ventilatory assistance. This delayed toxic phenomenon is thought to be due to the reentry of fentanyl into plasma from deposits in adipose tissue, muscle, and the gastrointestinal tract, leading to a secondary rise in the plasma concentration. It is more likely to be encountered when hypothermia, rewarming, and acidosis are present in the postoperative period. This life-threatening complication is treacherous, since it may occur when the patient has been transferred to the surgical ward and is less closely monitored.

Aged↗

PubMed1986

Voluntary respiratory effects of butorphanol and fentanyl following barbiturate induction: a double-blind study.

Thirty-one healthy women undergoing outpatient gynecologic surgery were given either butorphanol or fentanyl following barbiturate induction, and various respiratory parameters were measured at intervals after administration of the study drugs. Both fentanyl and butorphanol caused comparable decrements in tidal volume and other respiratory parameters. However, seven of the 15 patients receiving fentanyl had significant respiratory depression that required assisted ventilation. One of the butorphanol patients experienced a 45-second self-limited respiratory depression. One of three butorphanol patients experiencing side effects required treatment for these effects, compared with seven of nine fentanyl patients who experienced adverse effects. It is concluded that butorphanol and fentanyl have comparable anesthetic effects, but butorphanol is safer in terms of respiratory and adverse effects.

Adolescent↗

PubMed1996

Effect of fentanyl citrate analgesia on glucose production following trauma in rats.

The postoperative hormonal milieu enhances glucose production. The objectives of this study were to determine whether fentanyl plus pentobarbital anesthesia reduced the excretion of stress hormones and whether this resulted in decreased glucose production following trauma. Male Sprague-Dawley rats were assigned into control and trauma. The trauma group was further subdivided into three groups according to the methods of anesthesia: T-1, pentobarbital (PB) alone; T-2, pentobarbital plus fentanyl (FE); and T-3, given PB during surgery and FE at the end of surgery. Glucose production was measured by a primed constant infusion of 3-3H-glucose. Fentanyl plus pentobarbital anesthesia prevented an increase in corticosterone levels in the plasma compared with in T-1 and T-3, 0.5 hr after the surgery. Fentanyl plus pentobarbital, anesthesia caused reductions of insulin and glucagon levels in the plasma and a decrease in catecholamines excretion in the urine. Glucose production was lower with FE+PB anesthesia than with PB alone (PB: 4.6 +/- 0.1 mg/kg/min vs PB+FE: 3.6 +/- 0.2 mg/kg/min, P < 0.05). However, fentanyl given at the end of surgery did not alter hormonal milieu and glucose production compared with pentobarbital alone. Blocking afferent neural stimuli from the wound and injury during the surgery is one approach to prevent an enhancement of postoperative glucose production.

Analgesia↗

PubMed1991

Transdermal fentanyl for the treatment of pain after major urological operations. A randomized double-blind comparison with placebo using intravenous patient-controlled analgesia.

Transdermal fentanyl 75 micrograms/h (Fentanyl-TTS) was compared with placebo in a randomized double-blind study in the early postoperative period, using 50 patients recovering from major urological operations. Analgesic efficacy was individually titrated with intravenous fentanyl by means of a PCA pump (demand dose 34 micrograms, lockout time 5 min). The test systems were applied 8 h before anaesthesia and were left in situ for 24 h. During the PCA period (18.2 h) patients with Fentanyl-TTS required significantly less additional fentanyl (0.48 vs 0.93 micrograms.kg-1.h-1) and reported less pain than patients in the placebo-group. Patient acceptance was high in both groups. Side-effects were of only minor intensity and did not differ between the two groups. In particular, there was no case of clinically relevant respiratory depression.

Administration, Cutaneous↗

PubMed1975

The effect of diazepam and fentanyl on mental, psychomotor and electroencephalographic functions and their rate of recovery.

Ten healthy male subjects received diazepam (10 or 20 mg), fentanyl (0.1 or 0.2 mg) or a placebo intravenously at weekly intervals according to a latin square design. They were tested on a battery of psychological and electroencephalographic tests at 0.5, 2, 6, and 8 hrs following injection. Fentanyl had little effect on memory while diazepam reduced the ability to learn without increasing forgetting of material alread acquired. By the 2nd hour post injection, only the low dose of fentanyl had no residual effect. Recovery was complete by the 6th hour for all treatments according to the psychological tests except for the lagging effect of high dose of diazepam on memory. The electroencephalographic effects of diazepam persisted beyond the end of the testing sessions while those of the high dose of fentanyl recovered by the 8th hour. Thus in the dosages tested, diazepam had more intense and prolonged effects than fentanyl.

Adult↗

PubMed1977

Central sites and mechanisms of the hypotensive and bradycardic effects of the narcotic analgesic agent fentanyl.

In dogs, anaesthetized with chloralose, fentanyl (5 mug/kg i.v.) augmented the bradycardia produced by electrical stimulation of the carotid sinus nerves. In contrast, the same dose of the drug did not change the bradycardic response to stimulation of the nucleus of the solitary tract (NTS) indicating that a central facilitation of baroreceptor impulses occurs within the NTS, probably at the first synapse of baroreceptor reflex fibres. Bilateral destruction of the NTS caused a fulminating hypertension and tachycardia similar to that after cutting the baroreceptor afferent fibres. After both procedures, fentanyl (20 mug/kg i.v.) produced marked hypotension and bradycardia. The bradycardic effect was abolished by cutting both vagal nerves when the dogs were pretreated with a beta-adrenoceptor blocking agent (S 2395, 50 mug/kg i.v.). The results provide evidence that the NTS is not the main site of action either for the hypotensive effect or for the vagally mediated bradycardia of fentanyl. Since the dorsal nucleus of the vagal nerve was destroyed together with the NTS, this nucleus does also not appear to be a major site of the action of fentanyl. Blockade of dopamine receptors by haloperidol or pimozide or of serotonin receptors by methysergide did not change the hypotensive, bradycardic and sympathoinhibitory effects of fentanyl.

Adrenergic beta-Antagonists↗

PubMed1980

Fentanyl activates a particular population of vagal efferents which are cardioinhibitory.

In order to determine whether and how opiates affect vagal efferents, effects of fentanyl on single fibre discharge in the cervical vagus in dogs were studied. Dependent upon the responses to induced increases in blood pressure, 3 types of vagal efferents were classified: Type A (n = 9) with an increase, type B (n = 4) with a decrease and type C (n = 27) with no change in rate of discharge. Fentanyl (0.01 mg/kg i.v.) activated type A efferents which are considered as cardioinhibitory, but it did not activate type B and type C efferents. The activation was antagonized by naloxone. Cumulative doses of fentanyl (0.0025-0.16 mg/kg i.v.) produced a progressive increase in the discharge rate of type A efferents and a decrease in heart rate. These effects were maximum at 0.04 mg/kg (n = 7). Blood pressure was only slightly affected. The changes in discharge rate and heart rate were strongly and negatively correlated (r = -0.82, P less than 0.001). At maximum cardioinhibitory effects of fentanyl, blood pressure increases were able to further activate type A efferents and to decrease heart rate. The results show that fentanyl acts differentially on various vagal efferents. Only type A (cardioinhibitory) efferents are activated. It is hypothesized that the opiate receptor system in the brain plays a physiological role in the control of heart rate.

Animals↗

PubMed1987

The influence of hypothermia on the disposition of fentanyl--human and animal studies.

The effect of hypothermia on the disposition of fentanyl was evaluated in 18 children undergoing corrective cardiac surgery. They received a bolus of fentanyl followed by a continuous infusion which was stopped when cardiopulmonary bypass was established and profound hypothermia was achieved (18 degrees C-25 degrees C). Fentanyl plasma concentration remained essentially unchanged during hypothermia (6.45 ng/ml 5 min into hypothermia and 5.26 ng/ml 100-140 min later; p greater than 0.1). In subsequent experiments, the effect of hypothermia on the pharmacokinetics of fentanyl was studied in 4 piglets serving as their own controls. Both distribution volume (Vz) and total body clearance (CL) were significantly smaller during hypothermia. Our studies indicate that being a drug with a large distribution volume and a high hepatic extraction ratio, both CL and Vz are significantly reduced by hypothermia-induced hypoperfusion. In addition, TBC is influenced by the temperature-dependent hepatic metabolism of fentanyl.

Adolescent↗

PubMed1987

Transdermal absorption of fentanyl and sufentanil in man.

We have studied the transdermal absorption of tritiated fentanyl (citrate and base) and sufentanil citrate. Approximately 50 micrograms of drug in water was applied to the forearm skin of volunteers (5 subjects for fentanyl citrate and base, 6 for sufentanil). When the water had evaporated the site was covered with an occlusive dressing. Total urine collections were carried out for 96 h in 12 h periods. At 24 h the dressing was removed and skin removed with serial applications of adhesive tape. The radioactivity in the urine and on the tape was measured in a scintillation counter. Urine recovery expressed as a percentage of the absorbed dose was 17.9 +/- 1.9% for fentanyl citrate, 20.5 +/- 5.6% for fentanyl base, and 22.5 +/- 2.5% for sufentanil. In one subject who ran 10 miles with a sufentanil patch in situ the recovery was 52.3%. The systemic availability of fentanyl by this route is approximately 30% of that found using the intravenous route.

Administration, Cutaneous↗

PubMed1993

Tissue distribution of fentanyl and alfentanil in the rat cannot be described by a blood flow limited model.

Traditionally, physiological pharmacokinetic models assume that arterial blood flow to tissue is the rate-limiting step in the transfer of drug into tissue parenchyma. When this assumption is made the tissue can be described as a well-stirred single compartment. This study presents the tissue washout concentration curves of the two opioid analgesics fentanyl and alfentanil after simultaneous 1-min iv infusions in the rat and explores the feasibility of characterizing their tissue pharmacokinetics, modeling each of the 12 tissues separately, by means of either a one-compartment model or a unit disposition function. The tissue and blood concentrations of the two opioids were measured by gas-liquid chromatography. The well-stirred one-compartment tissue model could reasonably predict the concentration-time course of fentanyl in the heart, pancreas, testes, muscle, and fat, and of alfentanil in the brain and heart only. In most other tissues, the initial uptake of the opioids was considerably lower than predicted by this model. The unit disposition functions of the opioids in each tissue could be estimated by nonparametric numerical deconvolution, using the arterial concentration times tissue blood flow as the input and measured tissue concentrations as the response function. The observed zero-time intercepts of the unit disposition functions were below the theoretical value of one, and were invariably lower for alfentanil than for fentanyl. These findings can be explained by the existence of diffusion barriers within the tissues and they also indicate that alfentanil is less efficiently extracted by the tissue parenchyma than the more lipophilic compound fentanyl. The individual unit disposition functions obtained for fentanyl and alfentanil in 12 rat tissues provide a starting point for the development of models of intratissue kinetics of these opioids. These submodels can then be assembled into full physiological models of drug disposition.

Adipose Tissue↗

PubMed1994

Epidural fentanyl and sufentanil for intra- and postoperative analgesia. A randomized, double-blind comparison.

In a double-blind, randomized study the efficacies of concentrated fentanyl and sufentanil injections as intraoperative epidural analgesics were compared. Also, the equivalent dose of fentanyl and sufentanil administered by continuous infusion during the first 24 h postoperatively, expressed in analgesia and also considering the side-effects was determined. 53 Patients undergoing elective thoracotomy, aortic surgery and bowel surgery were randomized and treated double-blind with fentanyl 0.250 mg/ml or sufentanil 0.05 mg/ml. Preoperatively, 0.5-1 ml study medication was administered, followed by increments of 0.2-0.5 ml during surgery guided by heart rate and systolic blood pressure. Postoperatively, study medication diluted in 1.25 mg/l bupivacaine was administered by continuous epidural infusion. The infusion rate was adjusted to optimize analgesia. Dose, heart rate and systolic blood pressure were measured intra- and postoperatively. Pain, sedation, nausea and pruritus were assessed on a 10 cm visual analogue scale. There were no differences in required volume of study medication, heart rate and systolic blood pressure nor in the parameters assessed postoperatively. Administered doses were 27.5 micrograms/h fentanyl and 5.5 micrograms/h sufentanil. It was concluded that 0.250 mg/ml (0.74 mumol/ml) fentanyl is clinically equivalent to 0.050 mg/ml (0.13 mumol/ml) sufentanil.

Adolescent↗

PubMed1988

A comparison of alfentanil and fentanyl in short surgical procedures with special reference to postoperative effects.

A comparison of alfentanil and fentanyl was made with special reference to their postoperative effects. The study was performed double-blind in one hundred patients of either sex, undergoing elective surgery for hernia nuclei pulposi. All patients received thiopental, pancuronium, droperidol and 1-2 ml of a randomly selected ampoule, containing either 0.5 mg per ml alfentanil or 0.05 mg per ml fentanyl, for induction of anaesthesia. After positioning the patient, a 3-4 ml bolus dose of the analgesic was administered and occasional increments were given thereafter. There were significantly fewer responses to intubation in the 'alfentanil patients' than in the 'fentanyl patients'. Extubation time, although of little clinical importance, was significantly shorter in the alfentanil group. 12 Patients who were treated with alfentanil and 10 patients who were treated with fentanyl required the administration of an analgesic after mean time intervals of 65 and 64 min, respectively. Recovery of consciousness was similar in the two groups, but alertness 45 min after completion of the operation was significantly better in the alfentanil group: 52% were fully awake, as compared with 30% after administration of fentanyl.

Adult↗

PubMedDate not supplied

Comparison of meperidine plus midazolam and fentanyl plus midazolam in procedural sedation: a double-blind, randomized controlled trial.

This double-blind, randomized, prospective study was conducted to compare the analgesic and sedative efficacy of fentanyl and meperidine in orthopedic closed reduction of fractures and dislocations undertaken in the emergency department. Seventy consecutive adult patients with fractures or dislocations suitable for reduction were randomized to receive fentanyl (1 mcg/kg; n = 36) or meperidine (0.5 mg/kg; n = 34) in combination with midazolam (0.02 mg/kg). Vital signs and alertness scale scores of the patients were monitored. The Visual Analog Scale (VAS) was used to determine the degree of pain. There was no statistically significant difference between the VAS mean scores of the fentanyl and meperidine groups (t test, P = .772). The need for additional analgesic drugs was significantly more frequent in patients receiving meperidine (P = .018). No adverse events, such as hypotension or respiratory depression, were noted. Euphoria occurred in one patient in the fentanyl group. Although dose requirements differ, fentanyl and meperidine provide effective and reliable analgesia in closed reduction of fractures and dislocations.

Adult↗

PubMed1977

Effects of althesin, etomidate and fentanyl on haemodynamics and myocardial oxygen consumption in man.

The acute effects of althesin, etomidate and fentanyl upon haemodynamics, myocardial contractility and oxygen comsumption of the heart were studied in healthy premedicated patients (n = 15) lightly anaesthetized with N2O-O2 (ratio 2:1), 0.3 volumes per cent of halothane and isoflurane respectively. All individuals were ventilated at a normal level. The patients (n = 9) in the halothane group received etomidate 0.3 mg/kg and 20 minutes later althesin 0.075 ml/kg intravenously. In a second group of 6 patients on isoflurane fentanyl 0.01 mg/kg was given. Etomidate did not affect the cardiovascular system significantly. While the decrease in blood pressure after althesin (24 per cent) was the result of a reduction in total peripheral resistance (32 per cent), hypotension associated with fentanyl (23 per cent) was caused by diminished output due to bradycardia (18 per cent). Load data,heart rate, and maximum dp/dt indicated moderate negative inotropic properties only of althesin. Using the complex haemodynamic parameter developed by Bretschneider the myocardial oxygen consumption was calculated. The energy demand of the heart decreased with etomidate, althesin and fentanyl by 14 per cent, 16 per cent and 32 per cent respectively. It is concluded that the risk of cardiovascular depression at induction in patients with impaired myocardial performance and coronary insufficiency can be minimized with etomidate and/or fentanyl.

Adult↗