Trial Outcomes & Findings for Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage (NCT NCT03872700)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

Baseline

Results posted on

2023-08-15

Participant Flow

Enrollment commenced in August 2019, was temporarily suspended from March 2020 through June 2020 due to COVID-19. Enrollment was permanently halted by the data safety monitoring committee in April 2021 due to inadequate accrual. During the 19 months in which the study was open for enrollment, 176 patients were screened for eligibility and 49 patients were enrolled.

Participant milestones

Participant milestones
Measure	Intranasal Fentanyl 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
Overall Study STARTED	24	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc	Total n=49 Participants Total of all reporting groups
Age, Continuous	36.4 years STANDARD_DEVIATION 11 • n=24 Participants	36.8 years STANDARD_DEVIATION 10.3 • n=25 Participants	36.6 years STANDARD_DEVIATION 10.7 • n=49 Participants
Sex: Female, Male Female	10 Participants n=24 Participants	11 Participants n=25 Participants	21 Participants n=49 Participants
Sex: Female, Male Male	14 Participants n=24 Participants	14 Participants n=25 Participants	28 Participants n=49 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 participants n=24 Participants	25 participants n=25 Participants	49 participants n=49 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
Numerical Rating Scale (NRS) Pain Score at Baseline	8.3 score on a scale Standard Deviation 1.5	8.1 score on a scale Standard Deviation 2.9

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
NRS Pain Score After Lidocaine Injection	8.4 score on a scale Standard Deviation 2.7	8.0 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: Measured once anytime up to 60 minutes following intranasal administration

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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
NRS Pain Score Following Incision	3.9 score on a scale Standard Deviation 3.6	3.9 score on a scale Standard Deviation 3.8

PRIMARY outcome

Timeframe: Measured once anytime up to 60 minutes following intranasal administration

Population: Only 22 patients in each arm received 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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=22 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=22 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
NRS Pain Score After Blunt Dissection	4.1 score on a scale Standard Deviation 4.0	4.4 score on a scale Standard Deviation 3.8

PRIMARY outcome

Timeframe: Measured once anytime up to 60 minutes following intranasal administration

Population: Only 23 patients in the Intranasal Fentanyl arm and only 21 patients in the Placebo arm received 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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=23 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=21 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
NRS Pain Score After Irrigation	3.4 score on a scale Standard Deviation 3.8	2.6 score on a scale Standard Deviation 3.4

PRIMARY outcome

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

Population: Only 23 patients in the Intranasal Fentanyl arm and only 22 patients in the Placebo arm received 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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=23 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=22 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
NRS Pain Score After Packing of Abscess	4.5 score on a scale Standard Deviation 3.9	3.9 score on a scale Standard Deviation 3.8

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
Numerical Rating Scale (NRS) Pain Score for Overall Procedure	6.2 score on a scale Standard Deviation 3.3	7.0 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 120 minutes

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.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=24 Participants 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 Participants 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
Patient Satisfaction With Analgesia Not Satisfied with Analgesia	1 Participants	4 Participants
Patient Satisfaction With Analgesia Neutral (neither satisfied nor dis-satisifed)	9 Participants	13 Participants
Patient Satisfaction With Analgesia Satisfied with Analgesia	14 Participants	8 Participants

SECONDARY outcome

Timeframe: 120 minutes

Population: This study was formally completed as per Albert Einstein College of Medicine IRB records. Data was not collected for the Health care providers reported perception of study medication compared to usual care' outcome and as such an assessment of whether study medication provided a better, worse, or similar outcome as compared to usual care, from a provider perspective, was unable to be made

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.

Outcome measures

Outcome data not reported

Adverse Events

Intranasal Fentanyl

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intranasal Fentanyl n=24 participants at risk 2 mcg/kg INF, administered via intranasal route by atomizer syringe Intranasal fentanyl: Fentanyl Citrate	Placebo n=25 participants at risk 0.04ml/kg of sterile water, administered via intranasal route by atomizer syringe Placebo: Sterile Water Up to 5Cc
Nervous system disorders Dizziness	8.3% 2/24 • Number of events 2 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.	8.0% 2/25 • Number of events 2 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.
Nervous system disorders Drowsiness	8.3% 2/24 • Number of events 2 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.	0.00% 0/25 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.
Nervous system disorders Headache	0.00% 0/24 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.	4.0% 1/25 • Number of events 1 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.
Psychiatric disorders Sadness	0.00% 0/24 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.	4.0% 1/25 • Number of events 1 • Up to 60 minutes following initiation of treatment administration Subjects were assessed for medication-related adverse effects by being queried for the onset of any new symptoms that began following receipt of the study medication. Affirmative responses were followed by an open-ended question eliciting details. All adverse events, including medication-related and non medication-related adverse events are summarized in the Adverse Events module.

Additional Information

Dr. Benjamin W Friedman

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place