Fentanyl Citrate Injection, USP is a sterile, nonpyrogenic solution of fentanyl citrate in water for injection. Fentanyl Citrate is a potent narcotic analgesic which is administered only by the intravenous or intramuscular routes of injection. Each milliliter contains fentanyl (as the citrate) 50 mcg (0.05 mg). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.7 (4.0 to 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner.
Fentanyl Citrate Injection is indicated:
− for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
− for use as a narcotic analgesic supplement in general or regional anesthesia.
− for administration with a neuroleptic such as droperidol injection as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
− for use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
Published Studies Related to Fentanyl
Assessment of the relative potency of fentanyl buccal tablet to intravenous
morphine in healthy volunteers using a thermally induced hyperalgesia pain model. 
This exploratory randomized, double-blind, placebo-controlled, 5-treatment,
5-period crossover study was conducted using a thermally induced hyperalgesia
pain model in 51 healthy volunteers (33 evaluable) to characterize the relative
potency of fentanyl buccal tablet (FBT) versus intravenous morphine...
Evaluation of analgesic efficacy of intra-articular bupivacaine, bupivacaine plus fentanyl, and bupivacaine plus tramadol after arthroscopic knee surgery. [2011.12]
PURPOSE: To compare the efficacy of intra-articular (IA) bupivacaine, bupivacaine-fentanyl, and bupivacaine-tramadol for relief of postoperative pain after arthroscopic knee surgery... CONCLUSIONS: On the primary outcome measure (VAS pain score), both bupivacaine with fentanyl and bupivacaine with tramadol were better than IA bupivacaine, and bupivacaine with fentanyl was better than that with tramadol. However, both the combinations were comparable to each other with regard to the secondary outcome measure (supplementary analgesic requirement). Thus IA bupivacaine-fentanyl appears to be the best combination for relief of postoperative pain in patients undergoing arthroscopic knee surgery, followed by IA bupivacaine-tramadol. LEVEL OF EVIDENCE: Level I, randomized controlled trial. Copyright (c) 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
A randomized control trial of patient-controlled epidural analgesia (PCEA) with and without a background infusion using levobupivacaine and fentanyl. [2011.12]
BACKGROUND: Continuous infusion associated with patient-controlled epidural analgesia (PCEA) is used in many maternal units. This randomized controlled study evaluated the effect of a 10 mL/h background infusion associated with a 10 mL-20 minutes lockout time demand-only PCEA protocol using L-bupivacaine plus fentanyl in terms of local anaesthetic consumption, pain management and maternal satisfaction... CONCLUSION: When a levobupivacaine plus fentanyl PCEA protocol with high volume boluses and long lockout interval is used for labour analgesia, the background infusion increased the total local anesthetic dose with no change in pain management and maternal satisfaction.
Effect of one minimum alveolar concentration sevoflurane with and without fentanyl on hemodynamic response to laryngoscopy and tracheal intubation. [2011.10]
BACKGROUND: Drug combinations can be used for optimum obtundation of the hemodynamic response to tracheal intubation. The objective of this trial was to compare the hemodynamic response to laryngoscopy and tracheal intubation after administration of 2 mug/kg fentanyl bolus or a placebo with 2% end tidal sevoflurane at induction of anesthesia... CONCLUSION: Addition of 2 mug fentanyl bolus to 1 MAC sevoflurane anesthesia at induction attenuated the hemodynamic response to a maximum of 15% above baseline values.
Effect of intravenous dezocine on fentanyl-induced cough during general anesthesia induction: a double-blinded, prospective, randomized, controlled trial. [2011.09.21]
PURPOSE: To evaluate the suppressive effect of intravenous dezocine on fentanyl-induced cough during the induction of general anesthesia... CONCLUSION: These results demonstrate that intravenous dezocine 0.1 mg/kg 10 min prior to induction was effective in suppressing fentanyl-induced cough in our patients.
Clinical Trials Related to Fentanyl
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl [Completed]
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after
epidural injection. The objective of this investigation was to compare the analgesic effect
of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.
DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital Săo Paulo.
METHODS: 29 patients were divided into two groups. During the postoperative period, in the
presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in
saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n =
15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl
intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL
epidural 0. 25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity
was evaluated by numerical scale and plasma concentrations of Fentanyl were measured
Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers [Completed]
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a
single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a
single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2
is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl,
evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial
are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare
the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability
and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 Âµg/h and Mylan Fentanyl Transdermal System [Completed]
The objective of this study was to investigate the effect of three different types of
occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h
manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25
mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of
each type of overlay worn with each fentanyl treatment was also assessed after patch
Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 Âµg/hr and Duragesic® 25 Âµg/hr [Terminated]
The objective of this study was to investigate the effect of clinical procedures on the drug
delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals
Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen
Pharmaceutica by ALZA Corporation.
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant [Completed]
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl
system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
Reports of Suspected Fentanyl Side Effects
Product Quality Issue (194),
Inadequate Analgesia (108),
Toxicity TO Various Agents (108),
Respiratory Arrest (84),
Cardiac Arrest (84),
Drug Administration Error (70),
Wrong Technique in Drug Usage Process (69),
Nausea (59), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Fentanyl has an overall score of 7. The effectiveness score is 6 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
Fentanyl review by 47 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || Chronic pain due to neck injury and surgeries|
|Dosage & duration:|| || 100 mcg and 25 mcg patches (dosage frequency: every 72 hours) for the period of 4 years|
|Other conditions:|| || GERD,Arthritis,HBP,Depression,Anxiety,VentricularTachycardia|
|Other drugs taken:|| || Elavil,,Zanaflex,Morphine Sulfate,Metoprolol,Digoxin,Lisinopril,Nitroglycerin,Aspirin,Multivitamin.|
|Benefits:|| || Pain reduction at a controlled rate over 72 hours|
|Side effects:|| || Local irritation due to the adhesive,dry mouth,mild constipation,mild memory loss,slowed motor responses |
|Comments:|| || Medication delivered by 2 topical patches of 100 and 25 mcg.patches changed every 72 hours.They were used in conjunction with 15 mgs of MSIR as needed up to twice daily for breakthrough pain.I was also prescribed 8 mgs.of Zanaflex at bedtime along with Elavil to treat the depression commonly associated with Chronic health conditions.|
Fentanyl review by 38 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Chronic Regional Pain Syndrome|
|Dosage & duration:|| || 25mg Patch taken 1 patch per day for the period of 6 months|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || Alleviated pain in the affected area of the arm. Reduced all other symptoms also of Chronic Regional Pain Syndrome. Allowed me to get a good noghts sleep without waking and needing to shower due to excessive sweating which is symptomatic of the condition.|
|Side effects:|| || Side effects were chronic constipation, for which I was prescribed Lactulose, headaches which would last for days, disturbed sleep patterns, vivid dreaming. The inability to concentrate for even moderate periods of time, dry mouth and sluggishness.|
|Comments:|| || The patches were prescribed following a consulatation with the local pain clinic and unsuccessful nerve blocks performed by both the pain clinic and the fracture consultant. After 6 months of side effects I decided to stop using the patches as I felt that the relief in pain was not matched by the quality of life provided by the use of the drug|
Page last updated: 2013-02-10