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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal fentanyl | Experimental | 2 mcg/kg INF, administered via intranasal route by atomizer syringe |
|
| Placebo | Experimental | 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal fentanyl | Drug | Fentanyl Citrate |
| |
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4093575 | Background | 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. | |
| 2729688 | Background | 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. |
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Enrollment commenced in August 2019, was temporarily suspended from March 2020 through June 2020 due to COVID-19. Enrollment was permanently halted by the data safety monitoring committee in April 2021 due to inadequate accrual. During the 19 months in which the study was open for enrollment, 176 patients were screened for eligibility and 49 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Fentanyl | 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate |
| FG001 | Placebo | 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Fentanyl | 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate |
| BG001 | Placebo | 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Up to 60 minutes following initiation of treatment administration
Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Fentanyl | 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin W Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2021 | Apr 18, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2021 | Apr 9, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000038 | Abscess |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Drug |
Sterile Water Up to 5Cc |
|
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 |
| 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 |
| 22460965 | Background | 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. |
| 15039693 | Background | 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. |
| 12883507 | Background | 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. |
| 8284721 | Background | 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. |
| 23447753 | Background | 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. |
| 24835497 | Background | 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. |
| 19281935 | Background | 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. |
| 23846749 | Background | 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. |
| 10339680 | Background | 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. |
| 1610035 | Background | 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. |
| 11219563 | Background | 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. |
| 9113948 | Background | 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. |
| 21489168 | Background | 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. |
| 20645689 | Background | 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. |
| 12859464 | Background | 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. |
| 20678689 | Background | 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. |
| 10764171 | 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. |
| 22647439 | Background | 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. |
| 26759658 | Background | 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. |
| 28119014 | Background | 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. |
| 17550344 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration |
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|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Measured once anytime up to 60 minutes following intranasal administration |
|
|
|
| Primary | 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. | Only 22 patients in each arm received Blunt Dissection | Posted | Mean | Standard Deviation | score on a scale | Measured once anytime up to 60 minutes following intranasal administration |
|
|
|
| Primary | 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. | Only 23 patients in the Intranasal Fentanyl arm and only 21 patients in the Placebo arm received Irrigation | Posted | Mean | Standard Deviation | score on a scale | Measured once anytime up to 60 minutes following intranasal administration |
|
|
|
| Primary | 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. | Only 23 patients in the Intranasal Fentanyl arm and only 22 patients in the Placebo arm received Packing of abscess | Posted | Mean | Standard Deviation | score on a scale | Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 120 minutes |
|
|
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| Secondary | 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. | This study was formally completed as per Albert Einstein College of Medicine IRB records. Data was not collected for the Health care providers reported perception of study medication compared to usual care' outcome and as such an assessment of whether study medication provided a better, worse, or similar outcome as compared to usual care, from a provider perspective, was unable to be made | Posted | 120 minutes |
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| 0 |
| 24 |
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | Placebo | 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc | 0 | 25 | 0 | 25 | 4 | 25 |
| Drowsiness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sadness | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Satisfied with Analgesia |
|