AbscessPhase 3NCT03872700
Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
A Phase 3 study testing Intranasal fentanyl in people with Abscess, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Abscess
- What is being tested?
- Intranasal fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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).
- Conditions
- Abscess
- Being tested
- Intranasal fentanyl, Placebo
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal fentanylDrug
Fentanyl Citrate
PlaceboDrug
Sterile Water Up to 5Cc
| Study group | Role | What they receive |
|---|---|---|
| Intranasal fentanyl | Experimental | 2 mcg/kg INF, administered via intranasal route by atomizer syringe Receives: Drug: Intranasal fentanyl |
| Placebo | Experimental | 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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: 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: 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: 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: 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: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
Secondary outcomes (2)
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.
Measured: 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.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Friedman, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872700
- Sponsor's protocol ID
- 2019-9925
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2019
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4093575Chudnofsky 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.
PubMed 2729688Qualls 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.
PubMed 22460965Rupp 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.
PubMed 15039693Brown 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.
PubMed 12883507Lewis 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.
PubMed 8284721Schmitz 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.
PubMed 23447753Bourne 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.
PubMed 24835497Chang 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.
PubMed 19281935Chang 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.
PubMed 23846749Singer 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.
PubMed 10339680McNamara 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.
PubMed 1610035Potter 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.
PubMed 11219563Petrack 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.
PubMed 9113948Borland 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.
PubMed 21489168
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency
- ClinicalTrials.gov ID
- NCT03872700
- Acronym / sponsor ID
- 2019-9925
- Conditions
- Abscess
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal fentanyl | Experimental | Drug: Intranasal fentanyl2 mcg/kg INF, administered via intranasal route by atomizer syringe |
| Placebo | Experimental | Drug: Placebo0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal fentanylFentanyl Citrate | Drug | Intranasal fentanyl |
| PlaceboSterile Water Up to 5Cc | Drug | Placebo |
Primary outcome
Numerical Rating Scale (NRS) Pain Score at Baseline
Time frame: 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.
NRS Pain Score After Lidocaine Injection
Time frame: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
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.
NRS Pain Score Following Incision
Time frame: Measured once anytime up to 60 minutes following intranasal administration
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.
NRS Pain Score After Blunt Dissection
Time frame: Measured once anytime up to 60 minutes following intranasal administration
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.
NRS Pain Score After Irrigation
Time frame: Measured once anytime up to 60 minutes following intranasal administration
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.
NRS Pain Score After Packing of Abscess
Time frame: Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
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.
Numerical Rating Scale (NRS) Pain Score for Overall Procedure
Time frame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
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.
2 secondary outcomes
Patient Satisfaction With Analgesia
Time frame: 120 minutes
Health Care Providers Reported Perception of Study Medication Compared to Usual Care
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4093575Halvorson 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.
- Background: PubMed 2729688Chudnofsky 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.
- Background: PubMed 22460965Qualls 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.
- Background: PubMed 15039693Rupp 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.
- Background: PubMed 12883507Brown 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.
- Background: PubMed 8284721Lewis 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.
- Background: PubMed 23447753Schmitz 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.
- Background: PubMed 24835497Bourne 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.
- Background: PubMed 19281935Chang 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.
- Background: PubMed 23846749Chang 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.
- Background: PubMed 10339680Singer 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.
- Background: PubMed 1610035McNamara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Friedman, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal fentanyl in people with Abscess, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) Pain Score at Baseline (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872700, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.