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Trial record 25 of 58737 for:    Placebo

Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study

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ClinicalTrials.gov Identifier: NCT00484393
Recruitment Status : Completed
First Posted : June 8, 2007
Results First Posted : March 18, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Brandi Newby, Fraser Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Pain
Interventions Drug: tetracaine 4% gel
Drug: Placebo
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tetracaine Then Placebo Placebo Then Tetracaine
Hide Arm/Group Description Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection) Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Tetracaine First Placebo First Total
Hide Arm/Group Description Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
2-6 months Number Analyzed 4 participants 3 participants 7 participants
4 3 7
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female 3 2 5
Male 1 1 2
1.Primary Outcome
Title To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
Hide Description Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score
Time Frame 2 visits, 1 month apart
Hide Outcome Measure Data
Hide Analysis Population Description
Each participant was evaluated for repsonse following tetracaine and following placebo
Arm/Group Title Tetracaine Placebo
Hide Arm/Group Description:
Tetracaine 4% gel 1g applied to injection site
Placebo cream (Aquatain) 1g applied to inejction site
Overall Number of Participants Analyzed 7 7
Mean (Full Range)
Unit of Measure: units on a scale
Parent score
7.3
(5 to 10)
7.3
(5 to 10)
FLACC at baseline
1.7
(0 to 9)
1.6
(0 to 6)
FLACC post injection
8.4
(6 to 10)
9.3
(8 to 10)
Change in FLACC
6.7
(1 to 9)
7.7
(3 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tetracaine Placebo
Hide Arm/Group Description

Tetracaine 4% gel 1g applied to injection site

tetracaine 4% gel: tetracaine applied prior to 1 injection

Placebo cream (Aquatain) 1g applied to inejction site

Placebo: placebo applied prior to 1 injection

All-Cause Mortality
Tetracaine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tetracaine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tetracaine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      0/7 (0.00%)    
Skin and subcutaneous tissue disorders     
Local skin reaction *  4/7 (57.14%)  4 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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: Brandi Newby
Organization: Fraser Health
Phone: 604-585-5666 ext 774374
Publications:
Suresh G, Zempsky WT, Schechter NL, Fox JL, Connor EM, Carlin D, Top FH, Weisman LE. IMpact-RSV Study Group Report. Pediatrics 1999;104(4):993-5.
Responsible Party: Brandi Newby, Fraser Health
ClinicalTrials.gov Identifier: NCT00484393     History of Changes
Other Study ID Numbers: 2007-041
First Submitted: June 6, 2007
First Posted: June 8, 2007
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: June 19, 2015