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Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224431
First Posted: October 20, 2010
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Blake Bulloch, Phoenix Children's Hospital
Results First Submitted: April 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: jtip needleless lidocaine injection

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Needleless Injection of Buffered Lidocaine needleless injection of buffered lidocaine prior to lumbar puncture
Normal Saline Via Needleless Injection needleless injection of normal saline prior to lumbar puncture

Participant Flow:   Overall Study
    Needleless Injection of Buffered Lidocaine   Normal Saline Via Needleless Injection
STARTED   30   30 
COMPLETED   30   25 
NOT COMPLETED   0   5 
not randomized                0                4 
no video record                0                1 



  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
Needleless Injection of Buffered Lidocaine needleless injection of buffered lidocaine prior to lumbar puncture
Normal Saline Via Needleless Injection needleless injection of normal saline prior to lumbar puncture
Total Total of all reporting groups

Baseline Measures
   Needleless Injection of Buffered Lidocaine   Normal Saline Via Needleless Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      30 100.0%      30 100.0%      60 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age [1] 
[Units: Days]
Mean (Standard Deviation)
 48  (15)   40  (18)   44  (17) 
[1] In days of age not years
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  53.3%      15  50.0%      31  51.7% 
Male      14  46.7%      15  50.0%      29  48.3% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures

1.  Primary:   Pain, Measured as Units on a Scale   [ Time Frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. ]

2.  Secondary:   Length of Cry   [ Time Frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Heart Rate   [ Time Frame: On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  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: Angelique Ferayorni
Organization: Phoenix Children's Hospital
phone: 602-546-1910
e-mail: aferayorni@phoenixchildrens.com



Responsible Party: Blake Bulloch, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01224431     History of Changes
Other Study ID Numbers: 09-014
First Submitted: September 30, 2010
First Posted: October 20, 2010
Results First Submitted: April 5, 2011
Results First Posted: June 14, 2011
Last Update Posted: September 20, 2017