Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

This study has been completed.
Sponsor:
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01224431
First received: September 30, 2010
Last updated: June 14, 2011
Last verified: June 2011
Results First Received: April 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, 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
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

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  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     30     30     60  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age [1]
[units: days]
Mean ± Standard Deviation
  48  ± 15     40  ± 18     44  ± 17  
Gender  
[units: participants]
     
Female     16     15     31  
Male     14     15     29  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
[1] In days of age not years



  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.   Safety Issue:   No

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.   Safety Issue:   No


  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


No publications provided


Responsible Party: Angelique Ferayorni/ Blake Bulloch, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01224431     History of Changes
Other Study ID Numbers: 09-014
Study First Received: September 30, 2010
Results First Received: April 5, 2011
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board