Fentanyl (Fentanyl Citrate) - Summary

FENTANYL SUMMARY

FENTANYL CITRATE
INJECTION, USP

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.

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NEWS HIGHLIGHTS

Published Studies Related to Fentanyl

Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. [2009.10.08]
Abstract Background and objectives: Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl, for the treatment of BTcP in opioid-tolerant patients with cancer...

Analgesia during abdominal aortic aneurysm endovascular repair: remifentanil vs. fentanyl-midazolam--a randomized controlled trial. [2009.09]
BACKGROUND AND OBJECTIVE: Endovascular repair offers a less surgically invasive procedure for abdominal aortic aneurysms but nevertheless, still requires analgesic sedative cover to ensure an acceptable level of patient comfort and cardiorespiratory stability. The peculiarity of this kind of operation is that painful stimuli are concentrated in specific moments separated by intervals devoid of pain, so the insurgence of pain can be predicted and prevented with a bolus of analgesic, making a continuous infusion not essential, but potentially useful in achieving a better analgesic stability. The primary objective of the study was pain control measured by Visual Analogue Scale; secondary endpoints were cardiorespiratory stability and an acceptable level of sedation... CONCLUSION: Both techniques were shown to be safe and most importantly effective in offering cardiovascular stability and analgesia for American Society of Anaesthesiologists III-IV patients undergoing endovascular abdominal aortic aneurysm repair. However, remifentanil continuous infusion proved to offer significantly more stable pain control compared with the currently used combination fentanyl-midazolam.

Morphine-based cardiac anesthesia provides superior early recovery compared with fentanyl in elective cardiac surgery patients. [2009.08]
BACKGROUND: Experimental and clinical data suggest that morphine possesses unique cardioprotective and antiinflammatory properties. In this clinical investigation, we sought to determine whether the choice of intraoperative opioid (morphine or fentanyl) influences early recovery after cardiac surgery... CONCLUSIONS: In patients undergoing elective cardiac surgery with cardiopulmonary bypass, postoperative quality-of-life measures and pain control during recovery were enhanced when morphine (40 mg) was administered intraoperatively as part of a balanced anesthetic technique compared with fentanyl.

The effects of dexmedetomidine and fentanyl on emergence characteristics after adenoidectomy in children. [2009.07]
This randomised controlled study evaluated the effects of fentanyl and dexmedetomidine on emergence characteristics of children having adenoidectomy and anaesthetised with sevoflurane. Ninety children, two to seven years of age and ASA physical status I, were studied.Further studies of dexmedetomidine safety and its interaction with other anaesthetic agents are required before recommending its routine use during general anaesthesia in children.

Subarachnoid morphine, bupivacaine and fentanyl as part of combined spinal-epidural analgesia for low anterior resection. A prospective, randomised, double-blind clinical trial. [2009.07]
This study was designed to compare the efficacy of subarachnoid morphine alone or in combination with bupivacaine and fentanyl for combined spinal-epidural analgesia in colorectal surgery... The addition of bupivacaine and fentanyl to subarachnoid morphine did not confer any advantage on postoperative visual analogue scale scores and tramadol use, but lowered the need for additional intraoperative intravenous fentanyl and epidural bupivacaine and prolonged the time to first analgesia request.

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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 São 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 simultaneously.

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 µg/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 removal.

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/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.

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PATIENT REVIEWS / RATINGS / COMMENTS

Fentanyl review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
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.
		Reported Results
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.