Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
NCT ID: NCT03872700
Last Updated: 2023-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2019-08-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intranasal fentanyl
2 mcg/kg INF, administered via intranasal route by atomizer syringe
Intranasal fentanyl
Fentanyl Citrate
Placebo
0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
Placebo
Sterile Water Up to 5Cc
Interventions
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Intranasal fentanyl
Fentanyl Citrate
Placebo
Sterile Water Up to 5Cc
Eligibility Criteria
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Inclusion Criteria
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.
Exclusion Criteria
* Prior adverse reaction or allergy to opioids.
* Patients who are pregnant
* Patients weight \> 100kg
* Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
* Medical condition that might affect metabolism or opioid analgesics such as cirrhosis (Child Pugh A or worse) or kidney impairment (CKD 3 or worse)
* Chronic malnutrition, severe hypovolemia (dehydration of blood loss) or hepatic disease
* Alcohol intoxication: history of alcoholism or the presence of alcohol intoxication as judged by the treating physician may alter pain perception and has previously increased adverse events.
* SBP \<100 mmHg: Opioids can produce peripheral vasodilation causing orthostasis.
* HR \< 60/min: Opioids can cause bradycardia.
* Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
* Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
* Patients using transdermal pain patches or oral opioid use \> 10 days in the prior month: frequent opioid use may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
* Patients with a history of traumatic brain injury, seizures or hallucinations
* Patients with anatomical anomalies or medical conditions precluding intranasal administration
18 Years
64 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. doi: 10.1016/0736-4679(85)90077-0.
Chudnofsky CR, Wright SW, Dronen SC, Borron SW, Wright MB. The safety of fentanyl use in the emergency department. Ann Emerg Med. 1989 Jun;18(6):635-9. doi: 10.1016/s0196-0644(89)80517-7.
Qualls ML, Mooney MM, Camargo CA Jr, Zucconi T, Hooper DC, Pallin DJ. Emergency department visit rates for abscess versus other skin infections during the emergence of community-associated methicillin-resistant Staphylococcus aureus, 1997-2007. Clin Infect Dis. 2012 Jul;55(1):103-5. doi: 10.1093/cid/cis342. Epub 2012 Mar 28.
Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
Brown JC, Klein EJ, Lewis CW, Johnston BD, Cummings P. Emergency department analgesia for fracture pain. Ann Emerg Med. 2003 Aug;42(2):197-205. doi: 10.1067/mem.2003.275.
Lewis LM, Lasater LC, Brooks CB. Are emergency physicians too stingy with analgesics? South Med J. 1994 Jan;87(1):7-9. doi: 10.1097/00007611-199401000-00002.
Schmitz G, Goodwin T, Singer A, Kessler CS, Bruner D, Larrabee H, May L, Luber SD, Williams J, Bhat R. The treatment of cutaneous abscesses: comparison of emergency medicine providers' practice patterns. West J Emerg Med. 2013 Feb;14(1):23-8. doi: 10.5811/westjem.2011.9.6856.
Bourne CL, Brewer KL, House J. Injectable lidocaine provides similar analgesia compared to transdermal lidocaine/tetracaine patch for the incision and drainage of skin abscesses: a randomized, controlled trial. J Emerg Med. 2014 Sep;47(3):367-71. doi: 10.1016/j.jemermed.2013.11.126. Epub 2014 May 14.
Chang AK, Bijur PE, Baccelieri A, Gallagher EJ. Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial. Am J Geriatr Pharmacother. 2009 Feb;7(1):1-10. doi: 10.1016/j.amjopharm.2009.02.002.
Chang AK, Bijur PE, Davitt M, Gallagher EJ. Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients. Drugs Aging. 2013 Sep;30(9):747-54. doi: 10.1007/s40266-013-0103-y.
Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
McNamara RM, Rousseau E, Sanders AB. Geriatric emergency medicine: a survey of practicing emergency physicians. Ann Emerg Med. 1992 Jul;21(7):796-801. doi: 10.1016/s0196-0644(05)81024-8.
Potter M, Schafer S, Gonzalez-Mendez E, Gjeltema K, Lopez A, Wu J, Pedrin R, Cozen M, Wilson R, Thom D, Croughan-Minihane M. Opioids for chronic nonmalignant pain. Attitudes and practices of primary care physicians in the UCSF/Stanford Collaborative Research Network. University of California, San Francisco. J Fam Pract. 2001 Feb;50(2):145-51.
Petrack EM, Christopher NC, Kriwinsky J. Pain management in the emergency department: patterns of analgesic utilization. Pediatrics. 1997 May;99(5):711-4. doi: 10.1542/peds.99.5.711.
Borland M, Milsom S, Esson A. Equivalency of two concentrations of fentanyl administered by the intranasal route for acute analgesia in children in a paediatric emergency department: a randomized controlled trial. Emerg Med Australas. 2011 Apr;23(2):202-8. doi: 10.1111/j.1742-6723.2011.01391.x. Epub 2011 Feb 8.
Panagiotou I, Mystakidou K. Intranasal fentanyl: from pharmacokinetics and bioavailability to current treatment applications. Expert Rev Anticancer Ther. 2010 Jul;10(7):1009-21. doi: 10.1586/era.10.77.
Paech MJ, Lim CB, Banks SL, Rucklidge MW, Doherty DA. A new formulation of nasal fentanyl spray for postoperative analgesia: a pilot study. Anaesthesia. 2003 Aug;58(8):740-4. doi: 10.1046/j.1365-2044.2003.03286.x.
Veldhorst-Janssen NM, Fiddelers AA, van der Kuy PH, Kessels AG, Theunissen HM, van der Hulst RR, Neef C, Marcus MA. Pharmacokinetics, analgesic effect, and tolerability of a single preprocedural dose of intranasal fentanyl in patients undergoing drain removal after breast reduction or augmentation surgery: A prospective, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Jul;32(7):1427-36. doi: 10.1016/j.clinthera.2010.07.001.
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.
Barrett MJ, Cronin J, Murphy A, McCoy S, Hayden J, an Fhaili S, Grant T, Wakai A, McMahon C, Walsh S, O'Sullivan R. Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: study protocol for a randomised controlled trial. Trials. 2012 May 30;13:74. doi: 10.1186/1745-6215-13-74.
Sutter ME, Wintemute GJ, Clarke SO, Roche BM, Chenoweth JA, Gutierrez R, Albertson TE. The Changing Use of Intravenous Opioids in an Emergency Department. West J Emerg Med. 2015 Dec;16(7):1079-83. doi: 10.5811/westjem.2015.10.28454. Epub 2015 Dec 14.
Imamoglu M, Aygun A, Bekar O, Erdem E, Cicek M, Tatli O, Karaca Y, Sahin A, Turkmen S, Turedi S. A retrospective analysis of nebulized versus intravenous fentanyl for renal colic. Am J Emerg Med. 2017 May;35(5):757-763. doi: 10.1016/j.ajem.2017.01.026. Epub 2017 Jan 15.
Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2019-9925
Identifier Type: -
Identifier Source: org_study_id
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