Abscess
Conditions
Brief 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 Emergency Department (ED).
Interventions
Fentanyl Citrate
DRUGPlacebo
Sterile Water Up to 5Cc
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Score for Overall Procedure | 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. |
| NRS Pain Score After Irrigation | 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 | 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 at Baseline | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Care Providers Reported Perception of Study Medication Compared to Usual Care | 120 minutes | 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. |
| Patient Satisfaction With Analgesia | 120 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Fentanyl 2 mcg/kg INF, administered via intranasal route by atomizer syringe
Intranasal fentanyl: Fentanyl Citrate | 24 |
| Placebo 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
Placebo: Sterile Water Up to 5Cc | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Placebo | Total | Intranasal Fentanyl |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 10.3 | 36.6 years STANDARD_DEVIATION 10.7 | 36.4 years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 49 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 3 / 24 | 4 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
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.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
Population: Only 22 patients in each arm received Blunt Dissection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | NRS Pain Score After Blunt Dissection | 4.1 score on a scale | Standard Deviation 4 |
| Placebo | NRS Pain Score After Blunt Dissection | 4.4 score on a scale | Standard Deviation 3.8 |
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.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
Population: Only 23 patients in the Intranasal Fentanyl arm and only 21 patients in the Placebo arm received Irrigation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | NRS Pain Score After Irrigation | 3.4 score on a scale | Standard Deviation 3.8 |
| Placebo | NRS Pain Score After Irrigation | 2.6 score on a scale | Standard Deviation 3.4 |
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.
Time frame: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | NRS Pain Score After Lidocaine Injection | 8.4 score on a scale | Standard Deviation 2.7 |
| Placebo | NRS Pain Score After Lidocaine Injection | 8.0 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
Population: Only 23 patients in the Intranasal Fentanyl arm and only 22 patients in the Placebo arm received Packing of abscess
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | NRS Pain Score After Packing of Abscess | 4.5 score on a scale | Standard Deviation 3.9 |
| Placebo | NRS Pain Score After Packing of Abscess | 3.9 score on a scale | Standard Deviation 3.8 |
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.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | NRS Pain Score Following Incision | 3.9 score on a scale | Standard Deviation 3.6 |
| Placebo | NRS Pain Score Following Incision | 3.9 score on a scale | Standard Deviation 3.8 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | Numerical Rating Scale (NRS) Pain Score at Baseline | 8.3 score on a scale | Standard Deviation 1.5 |
| Placebo | Numerical Rating Scale (NRS) Pain Score at Baseline | 8.1 score on a scale | Standard Deviation 2.9 |
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.
Time frame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Fentanyl | Numerical Rating Scale (NRS) Pain Score for Overall Procedure | 6.2 score on a scale | Standard Deviation 3.3 |
| Placebo | Numerical Rating Scale (NRS) Pain Score for Overall Procedure | 7.0 score on a scale | Standard Deviation 3.2 |
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.
Time frame: 120 minutes
Population: 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
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.
Time frame: 120 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intranasal Fentanyl | Patient Satisfaction With Analgesia | Not Satisfied with Analgesia | 1 Participants |
| Intranasal Fentanyl | Patient Satisfaction With Analgesia | Neutral (neither satisfied nor dis-satisifed) | 9 Participants |
| Intranasal Fentanyl | Patient Satisfaction With Analgesia | Satisfied with Analgesia | 14 Participants |
| Placebo | Patient Satisfaction With Analgesia | Not Satisfied with Analgesia | 4 Participants |
| Placebo | Patient Satisfaction With Analgesia | Neutral (neither satisfied nor dis-satisifed) | 13 Participants |
| Placebo | Patient Satisfaction With Analgesia | Satisfied with Analgesia | 8 Participants |