Trial Outcomes & Findings for Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study. (NCT NCT02437669)

Results Overview

Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

1 hour

Results posted on

2019-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intranasal Hydromorphone Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg. Hydromorphone: To be administered by intranasal route using mucosal atomization device.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Hydromorphone n=35 Participants Children who received intranasal hydromorphone
Age, Continuous	11 years n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	26 Participants n=99 Participants
Race/Ethnicity, Customized White	5 Participants n=99 Participants
Race/Ethnicity, Customized Black	3 Participants n=99 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=99 Participants
Baseline pain score	7 units on a scale STANDARD_DEVIATION 0.4 • n=99 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered

Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM

Outcome measures

Outcome measures
Measure	Intranasal Hydromorphone n=35 Participants Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg. Hydromorphone: To be administered by intranasal route using mucosal atomization device.
Score on Faces Pain Scale - Revised	4.7 units on a scale Interval 3.7 to 5.7

SECONDARY outcome

Timeframe: 6 hours

Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.

Outcome measures

Outcome measures
Measure	Intranasal Hydromorphone n=35 Participants Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg. Hydromorphone: To be administered by intranasal route using mucosal atomization device.
Number of Minor Adverse Events	39 Minor adverse events

SECONDARY outcome

Timeframe: 6 hours

Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.

Outcome measures

Outcome measures
Measure	Intranasal Hydromorphone n=35 Participants Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg. Hydromorphone: To be administered by intranasal route using mucosal atomization device.
Number of Major Adverse Events	0 Major adverse events

SECONDARY outcome

Timeframe: 1 hour

Population: Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered

Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU

Outcome measures

Outcome measures
Measure	Intranasal Hydromorphone n=35 Participants Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg. Hydromorphone: To be administered by intranasal route using mucosal atomization device.
Score on Verbal Numeric Rating Scale	5.1 units on a scale Interval 4.2 to 6.0

Adverse Events

Intranasal Hydromorphone

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intranasal Hydromorphone n=35 participants at risk Children who received intranasal hydromorphone
General disorders Sleepy, drowsy, or tired	31.4% 11/35 • 6 hours
General disorders Bad taste in mouth	22.9% 8/35 • 6 hours
General disorders Lightheaded, dizzy	22.9% 8/35 • 6 hours
General disorders Dry mouth	14.3% 5/35 • 6 hours
General disorders Rhinitis	8.6% 3/35 • 6 hours
General disorders Nausea	5.7% 2/35 • 6 hours
Nervous system disorders Confusion	2.9% 1/35 • 6 hours
Skin and subcutaneous tissue disorders Itchiness	2.9% 1/35 • 6 hours
Gastrointestinal disorders Vomiting	0.00% 0/35 • 6 hours
General disorders Warm sensation	0.00% 0/35 • 6 hours

Additional Information

Daniel S. Tsze, MD, MPH

Columbia University College of Physicians and Surgeons

Phone: 212-305-9825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place