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

Primary Purpose

Abscess

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Intranasal fentanyl

Placebo

About this trial

This is an interventional treatment trial for Abscess

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intranasal fentanyl

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Patient Satisfaction With Analgesia

Patient reported outcomes were measured and reported using the Descriptive Scale below: Descriptive Scale: satisfied with analgesia, neutral, not satisfied with analgesia *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.

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

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.

Full Information

NCT ID

NCT03872700

First Posted

January 24, 2019

Last Updated

July 25, 2023

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03872700

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abscess

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal fentanyl

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intranasal fentanyl

Intervention Description

Fentanyl Citrate

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sterile Water Up to 5Cc

Primary Outcome Measure Information:

Title

Numerical Rating Scale (NRS) Pain Score at Baseline

Description

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.

Time Frame

Baseline

Title

NRS Pain Score After Lidocaine Injection

Description

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.

Time Frame

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

Title

NRS Pain Score Following Incision

Description

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.

Time Frame

Measured once anytime up to 60 minutes following intranasal administration

Title

NRS Pain Score After Blunt Dissection

Description

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.

Time Frame

Measured once anytime up to 60 minutes following intranasal administration

Title

NRS Pain Score After Irrigation

Description

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.

Time Frame

Measured once anytime up to 60 minutes following intranasal administration

Title

NRS Pain Score After Packing of Abscess

Description

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.

Time Frame

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

Title

Numerical Rating Scale (NRS) Pain Score for Overall Procedure

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Patient Satisfaction With Analgesia

Description

Time Frame

120 minutes

Title

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

Description

Time Frame

120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Friedman, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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