Pain Clinical Trial
Official title:
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
NCT number | NCT02437669 |
Other study ID # | AAAP5709 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | April 2018 |
Verified date | May 2019 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Morgan Stanley Children's Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
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 Mar 13. pii: S0735-6757(19)30162-7. doi: 10.1016/j.ajem.2019.03.013. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Minor Adverse Events | Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis. | 6 hours | |
Secondary | Number of Major Adverse Events | Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone. | 6 hours | |
Secondary | Score on Verbal Numeric Rating Scale | 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 | 1 hour |
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