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).
Brief Title
Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
Completion Date
Completion Date Type
Actual
Conditions
Abscess
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
18 Years
NCT Id
NCT03872700
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-9925
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Numerical Rating Scale (NRS) Pain Score at Baseline
Outcome Time Frame
Baseline
Outcome Description
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.
Outcome Measure
NRS Pain Score After Lidocaine Injection
Outcome Time Frame
Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
Outcome Description
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.
Outcome Measure
NRS Pain Score Following Incision
Outcome Time Frame
Measured once anytime up to 60 minutes following intranasal administration
Outcome Description
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.
Outcome Measure
NRS Pain Score After Blunt Dissection
Outcome Time Frame
Measured once anytime up to 60 minutes following intranasal administration
Outcome Description
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.
Outcome Measure
NRS Pain Score After Irrigation
Outcome Time Frame
Measured once anytime up to 60 minutes following intranasal administration
Outcome Description
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.
Outcome Measure
NRS Pain Score After Packing of Abscess
Outcome Time Frame
Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
Outcome Description
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.
Outcome Measure
Numerical Rating Scale (NRS) Pain Score for Overall Procedure
Outcome Time Frame
Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
Secondary Outcomes
Outcome Description
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.
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.
Outcome Time Frame
120 minutes
Outcome Measure
Patient Satisfaction With Analgesia
Outcome Description
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.
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.
Outcome Time Frame
120 minutes
Outcome Measure
Health Care Providers Reported Perception of Study Medication Compared to Usual Care
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415