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

NCT02437669 | Completed Phase 2 Results DMC

• 1 other identifier: AAAP5709
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Intranasal; Hydromorphone; Pediatric; Emergency department

Outcome Measures

Primary Outcomes (1)

• Score on Faces Pain Scale - Revised

  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

  1 hour

Secondary Outcomes (3)

• Number of Minor Adverse Events

  6 hours

• Number of Major Adverse Events

  6 hours

• Score on Verbal Numeric Rating Scale

  1 hour

Study Arms (1)

Intranasal hydromorphone

EXPERIMENTAL

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.

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

To be administered by intranasal route using mucosal atomization device.

Also known as: Dilaudid

Intranasal hydromorphone

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Daniel S. Tsze, MD, MPH
• Organization: Columbia University College of Physicians and Surgeons

dst2141@columbia.edu

212-305-9825

Study Officials

• Daniel Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics at CUMC

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 28, 2019
• Results First Posted: May 8, 2019

Record last verified: 2019-05

Locations

US (1)