Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage

A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency

This randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of the overall procedure in adult patients undergoing lidocaine infiltration and subsequent abscess incision and drainage in the Emergency Department (ED).

Study Overview

• Status: Completed
• Conditions: Abscess
• Intervention / Treatment: Drug: Intranasal fentanyl; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presenting to the ED for an abscess requiring incision and drainage
• 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:

• Use of opioids or tramadol within past 7 days.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal fentanyl; 2 mcg/kg INF, administered via intranasal route by atomizer syringe	Drug: Intranasal fentanyl; Fentanyl Citrate
Experimental: Placebo; 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe	Drug: Placebo; Sterile Water Up to 5Cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Pain Score at Baseline	Patient reported pain scores at baseline. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Baseline
NRS Pain Score After Lidocaine Injection	Patient reported NRS pain scores after Lidocaine injection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
NRS Pain Score Following Incision	Patient reported NRS pain scores following Incision. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Blunt Dissection	Patient reported NRS pain scores after Blunt Dissection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Irrigation	Patient reported NRS pain scores after Irrigation. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Packing of Abscess	Patient reported pain after Packing of abscess. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
Numerical Rating Scale (NRS) Pain Score for Overall Procedure	Patient reported pain scores for overall Procedure assessed immediately after placement of dressing at the end of procedure. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.	Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Analgesia	Patient reported outcomes were measured and reported using the Descriptive Scale below: Descriptive Scale: satisfied with analgesia, neutral, not satisfied with analgesia *This is a non-numerical scale with 3 outcome response options as listed above. Satisfied is rated higher than neutral which is, in turn, rated higher than not satisfied.	120 minutes
Health Care Providers Reported Perception of Study Medication Compared to Usual Care	Provider perception of better, same or worse treatment compared to usual care Descriptive Scale: better, same, worse *This is a non-numerical scale with 3 outcome response options as listed above. Better is rated higher than same which is, in turn, rated higher than worse.	120 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence of adverse events	Up to 60 minutes
Side effects	Incidence of side effects	Up to 60 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 2019-9925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes