Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
Condition: Abscess
MeSH terms: Abscess
Intervention: Intranasal fentanyl; Placebo
Intervention description: Fentanyl Citrate; Sterile Water Up to 5Cc
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

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