Trial Outcomes & Findings for Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study (NCT NCT00484393)
NCT ID: NCT00484393
Last Updated: 2015-06-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
2 visits, 1 month apart
Results posted on
2015-06-19
Participant Flow
Participant milestones
| Measure |
Tetracaine Then Placebo
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 Then Tetracaine
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)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study
Baseline characteristics by cohort
| Measure |
Tetracaine First
n=4 Participants
Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
|
Placebo First
n=3 Participants
Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2-6 months
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 visits, 1 month apartPopulation: Each participant was evaluated for repsonse following tetracaine and following placebo
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
Outcome measures
| Measure |
Tetracaine
n=7 Participants
Tetracaine 4% gel 1g applied to injection site
|
Placebo
n=7 Participants
Placebo cream (Aquatain) 1g applied to inejction site
|
|---|---|---|
|
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
FLACC at baseline
|
1.7 units on a scale
Interval 0.0 to 9.0
|
1.6 units on a scale
Interval 0.0 to 6.0
|
|
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
Parent score
|
7.3 units on a scale
Interval 5.0 to 10.0
|
7.3 units on a scale
Interval 5.0 to 10.0
|
|
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
FLACC post injection
|
8.4 units on a scale
Interval 6.0 to 10.0
|
9.3 units on a scale
Interval 8.0 to 10.0
|
|
To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.
Change in FLACC
|
6.7 units on a scale
Interval 1.0 to 9.0
|
7.7 units on a scale
Interval 3.0 to 10.0
|
Adverse Events
Tetracaine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tetracaine
n=7 participants at risk
Tetracaine 4% gel 1g applied to injection site
tetracaine 4% gel: tetracaine applied prior to 1 injection
|
Placebo
n=7 participants at risk
Placebo cream (Aquatain) 1g applied to inejction site
Placebo: placebo applied prior to 1 injection
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Local skin reaction
|
57.1%
4/7 • Number of events 4
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place