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

NCT03872700 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2019-9925
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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).

Conditions

Abscess

Outcome Measures

Primary Outcomes (7)

• Numerical Rating Scale (NRS) Pain Score at 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.

  Baseline

• NRS Pain Score After Lidocaine Injection

  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.

  Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration

• NRS Pain Score Following Incision

  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.

  Measured once anytime up to 60 minutes following intranasal administration

• NRS Pain Score After Blunt Dissection

  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.

  Measured once anytime up to 60 minutes following intranasal administration

• NRS Pain Score After Irrigation

  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.

  Measured once anytime up to 60 minutes following intranasal administration

• NRS Pain Score After Packing of Abscess

  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.

  Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration

• Numerical Rating Scale (NRS) Pain Score for Overall Procedure

  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.

  Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration

Secondary Outcomes (2)

• Patient Satisfaction With Analgesia

  120 minutes

• Health Care Providers Reported Perception of Study Medication Compared to Usual Care

  120 minutes

Study Arms (2)

Intranasal fentanyl

EXPERIMENTAL

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

Drug: Intranasal fentanyl

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Intranasal fentanyl DRUG

Fentanyl Citrate

Intranasal fentanyl

Placebo DRUG

Sterile Water Up to 5Cc

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Abscess

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Benjamin W Friedman
• Organization: Montefiore Medical Center

befriedm@montefiore.org

718-920-6626

Study Officials

• Benjamin Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: March 13, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 15, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)