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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00330343
First received: May 24, 2006
Last updated: July 18, 2017
Last verified: July 2017
Results First Received: April 10, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pain
Nausea
Pruritus
Intervention: Drug: naloxone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
75 participants were consented, but only 64 participants participated in this study and were placed in the experimental arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Naloxone No text entered.

Participant Flow:   Overall Study
    Naloxone
STARTED   64 
COMPLETED   59 
NOT COMPLETED   5 
Lost to Follow-up                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 64 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      64 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 12  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32  50.0% 
Male      32  50.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   64 


  Outcome Measures

1.  Primary:   Number of Participants With Naloxone Side Effects   [ Time Frame: 0-48 hours after infusion begins ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Myron Yaster
Organization: JHU
phone: 9552393
e-mail: myaster1@jhmi.edu


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00330343     History of Changes
Other Study ID Numbers: 04-03-31-02
Study First Received: May 24, 2006
Results First Received: April 10, 2012
Last Updated: July 18, 2017