Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330343
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2006-05-24
Brief Title:
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in ChildrenAdolescents
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Optimal Dose of Prophylactic Naloxone in Ameliorating Opioid Induced Side Effects in Children and Adolescents Receiving Intravenous Patient Controlled Analgesia IVPCA Morphine for Moderate to Severe Pain A Pharmacodynamic Pharmacokinetic and Pharmacogenetic Study
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids namely itching nausea and vomiting Male and female inpatients of the Childrens Center of the Johns Hopkins Hospital who are greater than 6 and less than 18 years of age with acute moderate to severe pain and who are to be treated with intravenous Patient controlled analgesia IVPCA morphine will be eligible for inclusion in this study Patients will be recruited by a study investigator prior to the initiation of IVPCA therapy The majority of patients will be post operative patients and will start therapy and the investigational drug in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit The investigators plan on studying between 10 and 99 male and female patients over a 2 year period
Detailed Description:
In patients of all ages opioids are the cornerstone of management of moderate to severe pain Regardless of method of administration all opioids produce unwanted side effects including pruritus nausea and vomiting constipation urinary retention cognitive impairment tolerance dependence and rarely respiratory depression Based on the results of a previously completed randomized controlled trial children and adolescents with moderate to severe pain are now routinely treated in the Childrens Center of the Johns Hopkins Hospital with a low dose naloxone infusion 025 mcgkgHOUR whenever morphine intravenous patient controlled analgesia IVPCA or parentnurse controlled analgesia IVPNCA is initiated Although the previous study showed a marked reduction in the incidence and severity of pruritus and nausea approximately a third of the patients still experience these side effects The primary purpose of this study is to reduce this failure rate by determining if there is an optimal dose of naloxone to prevent opioid induced side effects as determined by a dose finding classic up down dose escalation method The second aim is to determine the pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone infusion rates attempted The investigators will measure morphine naloxone and their metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric method LCMSMS The final aim is to determine the pharmacogenetics of responders and non-responders using DNA isolated from patient blood To accomplish this the investigators will need a single blood collection from patients currently being treated with IVPCA morphine and low dose intravenous naloxone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None