Clinical trial NCT03872700: Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abscess
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain Score at Baseline
timeFrame: Baseline
measure: NRS Pain Score After Lidocaine Injection
timeFrame: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
measure: NRS Pain Score Following Incision
timeFrame: Measured once anytime up to 60 minutes following intranasal administration
measure: NRS Pain Score After Blunt Dissection
timeFrame: Measured once anytime up to 60 minutes following intranasal administration
measure: NRS Pain Score After Irrigation
timeFrame: Measured once anytime up to 60 minutes following intranasal administration
measure: NRS Pain Score After Packing of Abscess
timeFrame: Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
measure: Numerical Rating Scale (NRS) Pain Score for Overall Procedure
timeFrame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
Secondary outcomes:
measure: Patient Satisfaction With Analgesia
timeFrame: 120 minutes
measure: Health Care Providers Reported Perception of Study Medication Compared to Usual Care
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
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