We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01542125
First Posted: March 2, 2012
Last Update Posted: July 12, 2016
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):
University of Alberta
Results First Submitted: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Liposomal Lidocaine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
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
  Hide 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
  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 
Overall Participants Analyzed 
[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
  Hide 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
  Hide 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: 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
First Submitted: December 15, 2011
First Posted: March 2, 2012
Results First Submitted: June 5, 2015
Results First Posted: May 23, 2016
Last Update Posted: July 12, 2016