drugset / Trial / NCT01756651
Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
Non-randomizedParallel-groupSingle-blindSupportive care
Summary
The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.
Timeline
- Start
- 2013-02
- Primary completion
- 2016-05-10
- Completion
- 2016-05-10
Publications
- Background Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
- Background Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3. doi: 10.1159/000092051.
- Background Calleary JG, Masood J, Van-Mallaerts R, Barua JM. Nitrous oxide inhalation to improve patient acceptance and reduce procedure related pain of flexible cystoscopy for men younger than 55 years. J Urol. 2007 Jul;178(1):184-8; discussion 188. doi: 10.1016/j.juro.2007.03.036. Epub 2007 May 17.
- Background Song YS, Song ES, Kim KJ, Park YH, Ku JH. Midazolam anesthesia during rigid and flexible cystoscopy. Urol Res. 2007 Jun;35(3):139-42. doi: 10.1007/s00240-007-0091-7. Epub 2007 Apr 6.
- Background Hruby G, Ames C, Chen C, Yan Y, Sagar J, Baron P, Landman J. Assessment of efficacy of transcutaneous electrical nerve stimulation for pain management during office-based flexible cystoscopy. Urology. 2006 May;67(5):914-7. doi: 10.1016/j.urology.2005.11.043.
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- Background Striebel HW, Kramer J, Luhmann I, Rohierse-Hohler I, Rieger A. [Pharmacokinetics of intranasal Fentanyl.]. Schmerz. 1993 Jun;7(2):122-5. doi: 10.1007/BF02527870. No abstract available. German.
- Background Toussaint S, Maidl J, Schwagmeier R, Striebel HW. Patient-controlled intranasal analgesia: effective alternative to intravenous PCA for postoperative pain relief. Can J Anaesth. 2000 Apr;47(4):299-302. doi: 10.1007/BF03020941.
- Background Saunders M, Adelgais K, Nelson D. Use of intranasal fentanyl for the relief of pediatric orthopedic trauma pain. Acad Emerg Med. 2010 Nov;17(11):1155-61. doi: 10.1111/j.1553-2712.2010.00905.x.
- Background Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.
- Background Borland ML, Bergesio R, Pascoe EM, Turner S, Woodger S. Intranasal fentanyl is an equivalent analgesic to oral morphine in paediatric burns patients for dressing changes: a randomised double blind crossover study. Burns. 2005 Nov;31(7):831-7. doi: 10.1016/j.burns.2005.05.001. Epub 2005 Jul 6.
- Background Foster D, Upton R, Christrup L, Popper L. Pharmacokinetics and pharmacodynamics of intranasal versus intravenous fentanyl in patients with pain after oral surgery. Ann Pharmacother. 2008 Oct;42(10):1380-7. doi: 10.1345/aph.1L168. Epub 2008 Aug 26.
- Background Christrup LL, Foster D, Popper LD, Troen T, Upton R. Pharmacokinetics, efficacy, and tolerability of fentanyl following intranasal versus intravenous administration in adults undergoing third-molar extraction: a randomized, double-blind, double-dummy, two-way, crossover study. Clin Ther. 2008 Mar;30(3):469-81. doi: 10.1016/j.clinthera.2008.03.001.
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- Background Fisher A, Watling M, Smith A, Knight A. Pharmacokinetics and relative bioavailability of fentanyl pectin nasal spray 100 - 800 microg in healthy volunteers. Int J Clin Pharmacol Ther. 2010 Dec;48(12):860-7. doi: 10.5414/cpp48860.
- Background Hansen MS, Mathiesen O, Trautner S, Dahl JB. Intranasal fentanyl in the treatment of acute pain--a systematic review. Acta Anaesthesiol Scand. 2012 Apr;56(4):407-19. doi: 10.1111/j.1399-6576.2011.02613.x. Epub 2012 Jan 19.
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- Background Prommer E, Thompson L. Intranasal fentanyl for pain control: current status with a focus on patient considerations. Patient Prefer Adherence. 2011 Mar 18;5:157-64. doi: 10.2147/PPA.S7665.
- Background Kress HG, Oronska A, Kaczmarek Z, Kaasa S, Colberg T, Nolte T. Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: a phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period. Clin Ther. 2009 Jun;31(6):1177-91. doi: 10.1016/j.clinthera.2009.05.022.
- Background Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 100 ug | Intranasal |
| Subject | Fentanyl | Other / unclassified | 200 ug | Intranasal |
Indications
No indication recorded.