Expired Study
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New York, New York 10032


Purpose:

Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It has not been previously studied in children, but may be a viable option for effectively and safely reducing pain in children by administering an analgesic by the intranasal route. This study will be a prospective, open-label pilot study of intranasal hydromorphone in children with moderate to severe acute pain presenting to the pediatric emergency department. The investigators aim to describe the amount of pain reduction associated with intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with a clinically meaningful improvement in acute pain.


Study summary:

Primary Aim: Determine the change in pain intensity in children with moderate to severe pain who receive intranasal hydromorphone one hour after administration. Secondary Aim(s): Describe the incidence of minor and major adverse events associated with intranasal hydromorphone in children with acute pain. The investigators will assess the patient's pain at baseline (prior to study drug administration), then after study drug administration: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and then every 30 minutes thereafter until 6 hours; administration of non-protocolized rescue medication administration (i.e. administered after first two rescue doses of IN hydromorphone); or discharge from emergency department (whichever comes first). The pain score at 60 minutes will be the primary outcome. The investigators will evaluate qualitative improvement in pain intensity at 15- and 30-minutes after study drug administration. If there is no improvement, or worsening of pain intensity, at each assessment, an additional rescue dose rescue dose of intranasal hydromorphone will be administered. After 60 minutes, the treating physician may administer any additional rescue medications at their discretion to treat the child's pain. The patient will be assessed for minor and major adverse events for the duration of the study.


Criteria:

Inclusion Criteria: - Age 4 to 17 years old, inclusive - Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more) - Requires parenteral opioid analgesic to treat their pain, as decided by treating physician Exclusion Criteria: - Allergy or known contraindication to receiving opioids - Receipt of any opioid or benzodiazepine within preceding 6 hours - Presence of intranasal obstruction that cannot be cleared readily - Cannot speak English or Spanish - Patient unlikely to be able to complete self-report measures of pain or questionnaires - Known liver or kidney problems - Currently critically ill - Chronic pain condition (e.g. sickle cell disease, fibromyalgia)


Study is Available At:


Original ID:

AAAP5709


NCT ID:

NCT02437669


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

4 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel Tsze, MD, MPH
Principal Investigator
Columbia University

Study Dates

Start Date:May 2015
Completion Date:April 2018
Completion Type:Actual
Primary Completion Date:April 2018
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 7, 2019
First Received Date:May 5, 2015
First Results Date:March 9, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Score on Faces Pain Scale - Revised
Time Frame:1 hour
Safety Issues:False
Description: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 fa
Outcome Type:Secondary Outcome
Measure:Number of Minor Adverse Events
Time Frame:6 hours
Safety Issues:False
Description:Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.
Outcome Type:Secondary Outcome
Measure:Number of Major Adverse Events
Time Frame:6 hours
Safety Issues:False
Description:Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.
Outcome Type:Secondary Outcome
Measure:Score on Verbal Numeric Rating Scale
Time Frame:1 hour
Safety Issues:False
Description: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 ma

Study Interventions

Intervention Type:Drug
Name:Hydromorphone
Description:To be administered by intranasal route using mucosal atomization device.
Arm Name:Intranasal hydromorphone
Other Name:Dilaudid

Study Arms

Study Arm Type:Experimental
Arm Name:Intranasal hydromorphone
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Tsze DS, Pan SS, DePeter KC, Wagh AM, Gordon SL, Dayan PS. Intranasal hydromorphone for treatment of acute pain in children: A pilot study. Am J Emerg Med. 2019 Jun;37(6):1128-1132. doi: 10.1016/j.ajem.2019.03.013. Epub 2019 Mar 13.
PMID:30902361

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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