Trial Outcomes & Findings for Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram (NCT NCT01925469)
NCT ID: NCT01925469
Last Updated: 2017-04-28
Results Overview
The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.
COMPLETED
PHASE4
30 participants
Pre-procedure (Baseline) and procedure (Time 0)
2017-04-28
Participant Flow
Participant milestones
| Measure |
Benzocaine
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine
|
Saline Spray
A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
Baseline characteristics by cohort
| Measure |
Benzocaine
n=15 Participants
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine
|
Saline Spray
n=15 Participants
A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
33.3 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
33.9 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Nulliparous
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Nulligravid
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
History of dysmenorrhea
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
History of chronic pelvic pain
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Pre-medication
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Bilateral obstruction
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Unilateral obstruction
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-procedure (Baseline) and procedure (Time 0)The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.
Outcome measures
| Measure |
Benzocaine
n=15 Participants
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine
|
Saline Spray
n=15 Participants
A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group
|
|---|---|---|
|
Change in Pain Score
|
50.6 mm
Interval -7.4 to 98.8
|
70.4 mm
Interval 19.8 to 100.0
|
SECONDARY outcome
Timeframe: 30 minutes post procedureThe patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.
Outcome measures
| Measure |
Benzocaine
n=15 Participants
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine
|
Saline Spray
n=15 Participants
A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group
|
|---|---|---|
|
Patient Satisfaction
Satisfied
|
2 participants
|
0 participants
|
|
Patient Satisfaction
Extremely satisfied
|
10 participants
|
10 participants
|
|
Patient Satisfaction
Very satisfied
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 5 minutesThe patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score
Outcome measures
| Measure |
Benzocaine
n=15 Participants
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine
|
Saline Spray
n=15 Participants
A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group
|
|---|---|---|
|
Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.
|
-11.1 mm
Interval -90.1 to 18.5
|
-37 mm
Interval -100.0 to 1.2
|
Adverse Events
Benzocaine
Saline Spray
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