Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage

Study Overview
=================
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).

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

Conditions
-----------------
Abscess

Intervention / Treatment
-----------------
* Drug: Intranasal fentanyl
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal fentanyl<br>2 mcg/kg INF, administered via intranasal route by atomizer syringe | Drug: Intranasal fentanyl<br>* Fentanyl Citrate<br>|
| Experimental: Placebo<br>0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe | Drug: Placebo<br>* Sterile Water Up to 5Cc<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 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 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 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 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 once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 120 minutes |