Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Johns Hopkins University.
Recruitment status was  Recruiting
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
First received: May 24, 2006
Last updated: May 25, 2006
Last verified: July 2005
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 Children’s 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 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. We plan on studying between 10 and 99, male and female patients over a 2 year period.

Condition Intervention
Drug: naloxone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Optimal Dose of Prophylactic Naloxone in Ameliorating Opioid Induced Side Effects in Children and Adolescents Receiving IVPCA Morphine for Moderate to Severe Pain: A Pharmacodynamic, Pharmacokinetic, and Pharmacogenetic Study

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • determine the lowest effective naloxone infusion dose to prevent opioid induced side effects

Secondary Outcome Measures:
  • determine morphine and naloxone pharmacokinetics
  • plasma level of naloxone required to prevent opioid induced effects and whether they are pharmacokinetic or pharmacogenetic in nature

Estimated Enrollment: 99
Study Start Date: May 2004
Estimated Study Completion Date: May 2005
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 Children’s Center of the Johns Hopkins Hospital with a low dose naloxone infusion (0.25 mcg/kg/HOUR) whenever morphine intravenous patient controlled analgesia (IVPCA) or parent/nurse 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 our 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. Our second aim is to detemine the pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone infusion rates attempted. We will measure morphine, naloxone, and their metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric method (LC/MS/MS). Our final aim is to determine the pharmacogenetics of responders and non-responders using DNA isolated from patient blood. To accomplish this we will need a single blood collection from patients currently being treated with IVPCA morphine and low dose intravenous naloxone.

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00330343

Contact: Myron Yaster, MD 410-955-2393 myaster@jhmi.edu

United States, Maryland
John Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Myron Yaster, MD    410-955-2393    myaster@jhmi.edu   
Principal Investigator: Myron Yaster, MD         
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Myron Yaster, MD Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00330343     History of Changes
Other Study ID Numbers: 04-03-31-02 
Study First Received: May 24, 2006
Last Updated: May 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
adverse effects

Additional relevant MeSH terms:
Narcotic Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016