Trial Outcomes & Findings for Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture (NCT NCT00676364)
NCT ID: NCT00676364
Last Updated: 2012-09-25
Results Overview
Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. "FACES" in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain.
COMPLETED
PHASE4
114 participants
Pain was measured immediately after venipuncture.
2012-09-25
Participant Flow
The study was conducted at one site of a multi-site, academic, community emergency department. Children between the ages of five and 18 years of age were considered for enrollment into the study if they were seen in the emergency department (ED) and a physician order was placed for intravenous cannulation or labs to be drawn by venipuncture.
A convenience sample was utilized due to the availability of the research study coordinator who completed the enrollment from 7 am to 5 pm Monday through Friday. One participant was excluded from analysis due to ineligibility.
Participant milestones
| Measure |
ControI Group Receiving Placebo Cream
Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
|
Investigational Group Receiving 4% Lidocaine
Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Baseline characteristics by cohort
| Measure |
ControI Group Receiving Placebo Cream Before Venipuncture
n=57 Participants
Experimential group receiving medicated topical cream prior to venipuncture
|
Investigational Group
n=57 Participants
Investigational group receiving blinded 4% lidocaine cream
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
11.6 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
11.6 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
11.6 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pain was measured immediately after venipuncture.Population: We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.
Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. "FACES" in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain.
Outcome measures
| Measure |
ControI Group Receiving Placebo Cream
n=57 Participants
Control group receiving placebo topical cream prior to venipuncture
|
Investigational Group
n=57 Participants
Investigational group receiving 4% lidocaine cream prior to venipuncture
|
|---|---|---|
|
Pain From Venipuncture
|
2.2 scores on a scale
Standard Deviation 1.4
|
2.1 scores on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: During venipuncturePopulation: We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.
Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.
Outcome measures
| Measure |
ControI Group Receiving Placebo Cream
n=57 Participants
Control group receiving placebo topical cream prior to venipuncture
|
Investigational Group
n=57 Participants
Investigational group receiving 4% lidocaine cream prior to venipuncture
|
|---|---|---|
|
Anxiety of Venipuncture
|
43.1 scores on a scale
Standard Deviation 36.5
|
40.5 scores on a scale
Standard Deviation 36.4
|
Adverse Events
ControI Group Receiving Placebo Cream
Investigational Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place