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

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ClinicalTrials.gov Identifier: NCT03872700
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Latev, Montefiore Medical Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Abscess Drug: Intranasal fentanyl Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) pain score for overall procedure [ Time Frame: baseline ]
    Pt reported pain scores for overall pain after dressing application. The NRS is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.

  2. NRS pain score after abscess incision and drainage procedure [ Time Frame: baseline ]
    Pt reported NRS pain scores after incision. The NRS is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.

  3. NRS pain score after instrumentation and packing [ Time Frame: Up to 60 minutes as the time of completion of application of the bandage. ]
    Pt reported pain after breaking of loculations, irrigation, and packing of abscess. The NRS is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.


Secondary Outcome Measures :
  1. Patient reported outcome of satisfaction with treatment: Descriptive Scale [ Time Frame: 120 minutes ]

    Pt reported outcomes will be measured by patients response to feeling satisfied, neutral, not satisfied with treatment

    Descriptive Scale: satisfied, neutral, not satisfied

    *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.


  2. Health care providers reported perception of study medication compared to usual care [ Time Frame: 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.



Other Outcome Measures:
  1. Adverse events [ Time Frame: Up to 60 minutes ]
    Incidence of adverse events

  2. Side effects [ Time Frame: Up to 60 minutes ]
    Incidence of side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872700


Contacts
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Contact: Alexander V Latev, MD 4254437245 ALEXLATEV@GMAIL.COM

Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Alexander Latev, MD Montefiore Medical Center
More Information
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Publications:

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Responsible Party: Alexander Latev, Professor, Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03872700     History of Changes
Other Study ID Numbers: 2019-9925
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Lidocaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General