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

Phase 3

Completed

Conditions: Abscess

Interventions: Drug: Intranasal fentanyl
Drug: Placebo

Registration Number: NCT03872700

Lead Sponsor: Montefiore Medical Center

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal fentanyl	Intranasal fentanyl	2 mcg/kg INF, administered via intranasal route by atomizer syringe
Placebo	Placebo	0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.