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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 3

Conditions: Abscess

Treatments: Drug: Intranasal fentanyl; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03872700

2019-9925

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

Intranasal fentanyl

Experimental group

Description:

2 mcg/kg INF, administered via intranasal route by atomizer syringe

Treatment:

Drug: Intranasal fentanyl

Placebo

Experimental group

Description:

0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe

Treatment:

Drug: Placebo