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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intranasal fentanyl 		2 mcg/kg INF, administered via intranasal route by atomizer syringe
  • Drug: Intranasal fentanyl
    Fentanyl Citrate
Experimental
Placebo 		0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe
  • Drug: Placebo
    Sterile Water Up to 5Cc

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.