A Phase 3 interventional study of Intranasal fentanyl and Placebo in Abscess, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by Montefiore Medical Center · Phase 3, Interventional, and Treatment
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).
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's enrollment of 49 is below the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 mcg/kg INF, administered via intranasal route by atomizer syringe
Drug: Intranasal fentanyl
0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
Drug: Placebo
Fentanyl Citrate
Sterile Water Up to 5Cc
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
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.
Time frame: 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.
Time frame: 120 minutes
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.
| Milestone | Intranasal Fentanyl | Placebo |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 25 |
| Not completed | 0 | 0 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Score at Baseline | 8.3 ± 1.5 | 8.1 ± 2.9 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| NRS Pain Score After Lidocaine Injection | 8.4 ± 2.7 | 8.0 ± 2.2 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| NRS Pain Score Following Incision | 3.9 ± 3.6 | 3.9 ± 3.8 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| NRS Pain Score After Blunt Dissection | 4.1 ± 4.0 | 4.4 ± 3.8 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| NRS Pain Score After Irrigation | 3.4 ± 3.8 | 2.6 ± 3.4 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| NRS Pain Score After Packing of Abscess | 4.5 ± 3.9 | 3.9 ± 3.8 |
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.
| score on a scale | Intranasal Fentanyl | Placebo |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Score for Overall Procedure | 6.2 ± 3.3 | 7.0 ± 3.2 |
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.
| Participants | Intranasal Fentanyl | Placebo |
|---|---|---|
| Not Satisfied with Analgesia | 1 | 4 |
| Neutral (neither satisfied nor dis-satisifed) | 9 | 13 |
| Satisfied with Analgesia | 14 | 8 |
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.
No measurements were reported for this outcome.
Collected over Up to 60 minutes following initiation of treatment administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Fentanyl | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| Placebo | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | Intranasal Fentanyl | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 2/24 | 2/25 |
| DrowsinessNervous system disorders | 2/24 | 0/25 |
| HeadacheNervous system disorders | 0/24 | 1/25 |
| SadnessPsychiatric disorders | 0/24 | 1/25 |
| Age, Continuous(years) | Intranasal Fentanyl | Placebo | Total |
|---|---|---|---|
| Mean | 36.4 ± 11 | 36.8 ± 10.3 | 36.6 ± 10.7 |
| Sex: Female, Male(Participants) | Intranasal Fentanyl | Placebo | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 14 | 14 | 28 |
| Race and Ethnicity Not Collected(Participants) | Intranasal Fentanyl | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intranasal Fentanyl | Placebo | Total |
|---|---|---|---|
| United States | 24 | 25 | 49 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl