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The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01542125
First received: December 15, 2011
Last updated: June 10, 2016
Last verified: June 2016
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Liposomal Lidocaine
Drug: Placebo

  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
Liposomal Lidocaine Group

Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing

Liposomal Lidocaine: 4% Liposomal Lidocaine

Placebo Group

This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.

Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes.


Participant Flow:   Overall Study
    Liposomal Lidocaine Group     Placebo Group  
STARTED     140     141  
COMPLETED     140     141  
NOT COMPLETED     0     0  



  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
Liposomal Lidocaine Group

Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing

Liposomal Lidocaine: 4% Liposomal Lidocaine

Placebo Group

This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.

Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes.

Total Total of all reporting groups

Baseline Measures
    Liposomal Lidocaine Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  140     141     281  
Age  
[units: years]
Mean (Standard Deviation)
  7.89  (3.71)     7.74  (3.74)     7.81  (3.71)  
Gender  
[units: participants]
     
Female     60     63     123  
Male     80     78     158  



  Outcome Measures

1.  Primary:   Pain   [ Time Frame: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes ]


  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: Research Coordinator
Organization: Alberta Health Services
phone: 780-492-2398
e-mail: manu.saraswat@albertahealthservices.ca



Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01542125     History of Changes
Other Study ID Numbers: RES0002737
Study First Received: December 15, 2011
Results First Received: June 5, 2015
Last Updated: June 10, 2016
Health Authority: Canada: Ethics Review Committee