A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency
Overview
- Phase
- Phase 3
- Intervention
- Intranasal fentanyl
- Conditions
- Abscess
- Sponsor
- Montefiore Medical Center
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Numerical Rating Scale (NRS) Pain Score at Baseline
- Status
- Completed
- Last Updated
- 2 years ago
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).
Investigators
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.
Arms & Interventions
Intranasal fentanyl
2 mcg/kg INF, administered via intranasal route by atomizer syringe
Intervention: Intranasal fentanyl
Placebo
0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
Intervention: Placebo
Outcomes
Primary Outcomes
Numerical Rating Scale (NRS) Pain Score at Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
NRS Pain Score After Irrigation
Time Frame: 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
Time Frame: 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 for Overall Procedure
Time Frame: 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.
Secondary Outcomes
- Patient Satisfaction With Analgesia(120 minutes)
- Health Care Providers Reported Perception of Study Medication Compared to Usual Care(120 minutes)