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An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Recruiting
I'm InterestedTrial ID: NCT00465647
Purpose
The primary objective of this study is to characterize the pharmacokinetics and
pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16
years inclusive. The secondary objectives are to characterize the safety and efficacy of
hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Official Title
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid
analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral
analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the
30 days prior to surgery.
Exclusion Criteria:
- Prospective subjects with clinically significant hepatic or renal dysfunction and
impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than
hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior
to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic
treatment with nonopioid medication within 6 hours prior to administration of first
dose of oral hydromorphone.
Other protocol-specific inclusion/exclusion criteria may apply.
Intervention(s):
drug: Hydromorphone
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Greg Hammer
6507237835