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

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ClinicalTrials.gov Identifier: NCT02437669
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : May 8, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Hydromorphone Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: 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.
Drug: Hydromorphone
To be administered by intranasal route using mucosal atomization device.
Other Name: Dilaudid




Primary Outcome Measures :
  1. Score on Faces Pain Scale - Revised [ Time Frame: 1 hour ]
    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


Secondary Outcome Measures :
  1. Number of Minor Adverse Events [ Time Frame: 6 hours ]
    Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.

  2. Number of Major Adverse Events [ Time Frame: 6 hours ]
    Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.

  3. Score on Verbal Numeric Rating Scale [ Time Frame: 1 hour ]
    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



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437669


Locations
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United States, New York
Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Daniel Tsze, MD, MPH Columbia University
  Study Documents (Full-Text)

Documents provided by Daniel S Tsze, MD, MPH, Columbia University:
Publications of Results:
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Responsible Party: Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics at CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT02437669    
Other Study ID Numbers: AAAP5709
First Posted: May 7, 2015    Key Record Dates
Results First Posted: May 8, 2019
Last Update Posted: May 28, 2019
Last Verified: May 2019
Keywords provided by Daniel S Tsze, MD, MPH, Columbia University:
Intranasal
Hydromorphone
Pediatric
Emergency department
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents