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Completed

NCT Number: NCT02437669

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

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.

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Key information

Conditions

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

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Morgan Stanley Children's Hospital

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydromorphone

Drug

To be administered by intranasal route using mucosal atomization device.

Other names: Dilaudid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 7, 2015
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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