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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330343
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pain
Intervention: Drug: naloxone

  Participant Flow

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
Naloxone No text entered.

Participant Flow:   Overall Study
Lost to Follow-up                5 

  Baseline Characteristics

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
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      64 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
[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

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

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


Responsible Party: Johns Hopkins University Identifier: NCT00330343     History of Changes
Other Study ID Numbers: 04-03-31-02
First Submitted: May 24, 2006
First Posted: May 26, 2006
Results First Submitted: April 10, 2012
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017