Trial Outcomes & Findings for Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children (NCT NCT01549002)

Results Overview

Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The four phases in the study are (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. The scores documented here are the total OSBD-R scores.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

Up to 10 minutes after the procedure completion

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Intranasal Fentanyl Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Overall Study STARTED	10	10
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intranasal Fentanyl Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Overall Study Excessive pain	0	2
Overall Study Moderate sedation required	0	2

Baseline Characteristics

Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Fentanyl n=10 Participants Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine n=10 Participants Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose	Total n=20 Participants Total of all reporting groups
Age, Continuous	15.3 years n=93 Participants	15.4 years n=4 Participants	15.4 years n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Observational Scale of Behavioral Distress - revised	0.06 units on a scale STANDARD_DEVIATION 0.13 • n=93 Participants	0.04 units on a scale STANDARD_DEVIATION 0.08 • n=4 Participants	0.05 units on a scale STANDARD_DEVIATION 0.1 • n=27 Participants

PRIMARY outcome

Timeframe: Up to 10 minutes after the procedure completion

Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The four phases in the study are (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. The scores documented here are the total OSBD-R scores.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=10 Participants Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine n=10 Participants Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)	5.48 units on a scale Standard Deviation 4.09	18.92 units on a scale Standard Deviation 14.82

SECONDARY outcome

Timeframe: Up to 10 minutes after procedure completion

Population: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.

The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain has strong validity and reliability in children 4 - 17 years of age undergoing painful procedures, and will be used to assess patients' self reported pain. A score of 0 means no pain, a score of 10 means very much pain. Therefore, a lower score indicates that a patient is experiencing a lower degree of pain intensity. Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I\&D, (3) immediately post I\&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=10 Participants Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine n=6 Participants Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Score on the Faces Pain Scale Revised (FPS-R) Before analgesia administration	6 units on a scale Interval 3.5 to 6.5	4 units on a scale Interval 1.5 to 6.0
Score on the Faces Pain Scale Revised (FPS-R) 10 min after analgesia, before I&D	2 units on a scale Interval 1.5 to 4.5	4 units on a scale Interval 0.0 to 6.0
Score on the Faces Pain Scale Revised (FPS-R) Immediately post-I&D	4 units on a scale Interval 0.0 to 8.0	10 units on a scale Interval 9.5 to 10.0
Score on the Faces Pain Scale Revised (FPS-R) 10 min after procedure completion	1 units on a scale Interval 0.0 to 4.0	5 units on a scale Interval 2.8 to 6.5

SECONDARY outcome

Timeframe: 10 minutes after procedure completion

Population: Patient satisfied with analgesia administered

Number of patients satisfied with analgesia administered will be evaluated by determining the number of patients who report a Likert scale response of "somewhat satisfied", "very satisfied", or "extremely satisfied" (i.e. any patient who selects any of these three responses will be considered to have been satisfied with analgesia administered). Patients will be asked 10 minutes after procedure completion. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey.

Outcome measures

Outcome measures
Measure	Intranasal Fentanyl n=10 Participants Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine n=10 Participants Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Number of Patients Satisfied With Analgesia Administered	10 Participants	4 Participants

Adverse Events

Intranasal Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Morphine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intranasal Fentanyl n=10 participants at risk Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I\&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare). The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose	Intravenous Morphine n=10 participants at risk Patients in this arm will receive intravenous morphine as their pre-I\&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push. The abscess I\&D will be followed according to protocol using topical and local anesthetic. Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Respiratory, thoracic and mediastinal disorders Oxygen desaturation	0.00% 0/10 Standardized cardiopulmonary monitoring and questionnaire.	10.0% 1/10 Standardized cardiopulmonary monitoring and questionnaire.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Fenster

ColumbiaU

Phone: 212-305-9825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place