Status:
COMPLETED
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
Lead Sponsor:
Johns Hopkins University
Conditions:
Pain
Nausea
Eligibility:
All Genders
7-17 years
Phase:
PHASE2
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, ...
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, na...
Eligibility Criteria
Inclusion
- Male and female patients greater than 6 and less than 18 years of age with acute, moderate to severe pain who are to start treatment with IVPCA morphine as inpatients of the Children's Center of the Johns Hopkins Hospital
Exclusion
- patients who require concomitant benzodiazepine administration
- allergic to opioids
- have been in an investigational drug trial within 1 month
- received opioids with in 7 days of the study
- parent with psychiatric illness which impairs their ability to provide consent parent who does not speak English
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00330343
Start Date
May 1 2004
End Date
June 1 2009
Last Update
July 19 2017
Active Locations (1)
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1
John Hopkins Hospital
Baltimore, Maryland, United States, 21287