Trial Outcomes & Findings for Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations (NCT NCT01680328)
NCT ID: NCT01680328
Last Updated: 2017-03-03
Results Overview
Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
1 minute (±30 sec) after each injection
Results posted on
2017-03-03
Participant Flow
The trial was conducted at a single site in Germany at a single visit.
Participant milestones
| Measure |
All Participants
Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
Subjects Missing Injections
|
2
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Baseline characteristics by cohort
| Measure |
All Participants
n=82 Participants
Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
|
|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Gender
Female
|
32 Participants
n=5 Participants
|
|
Gender
Male
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 minute (±30 sec) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).
Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Injection Pain (VAS mm)
Needle insertion
|
20.0 mm
Standard Deviation 24.2
|
12.8 mm
Standard Deviation 16.3
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
|
Injection Pain (VAS mm)
Injection speed at 150 μL/s; Abdomen
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
20.9 mm
Standard Deviation 24.4
|
15.7 mm
Standard Deviation 20.2
|
11.6 mm
Standard Deviation 15.7
|
14.5 mm
Standard Deviation 17.3
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
|
Injection Pain (VAS mm)
Injection speed at 300 μL/s; Abdomen
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
17.2 mm
Standard Deviation 22.5
|
20.1 mm
Standard Deviation 25.3
|
13.7 mm
Standard Deviation 17.1
|
14.8 mm
Standard Deviation 18.1
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
NA mm
Standard Deviation NA
Not administered
|
|
Injection Pain (VAS mm)
Injection speed at 450 μL/s; Abdomen
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
21.1 mm
Standard Deviation 24.8
|
14.9 mm
Standard Deviation 16.9
|
14.8 mm
Standard Deviation 18.9
|
12.4 mm
Standard Deviation 15.5
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
|
Injection Pain (VAS mm)
Injection volume of 400 μL; Thighs
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
20.9 mm
Standard Deviation 24.8
|
NA mm
Standard Deviation NA
Not administered
|
22.9 mm
Standard Deviation 25.9
|
|
Injection Pain (VAS mm)
Injection volume of 800 μL; Thighs
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
23.2 mm
Standard Deviation 24.5
|
NA mm
Standard Deviation NA
Not administered
|
|
Injection Pain (VAS mm)
Injection volume of 1600 μL; Thighs
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
No summary statistics done for this combination
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
NA mm
Standard Deviation NA
Not administered
|
31.1 mm
Standard Deviation 28.5
|
NA mm
Standard Deviation NA
Not administered
|
31.5 mm
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: 1 minute (±30 seconds) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Acceptance of Injection Pain After Injection of Different Volumes.
Yes
|
334 scores
|
218 scores
|
303 scores
|
368 scores
|
—
|
—
|
—
|
—
|
—
|
|
Acceptance of Injection Pain After Injection of Different Volumes.
No
|
75 scores
|
28 scores
|
25 scores
|
41 scores
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 minute (±30 sec) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Acceptance of Injection Pain After Injection at Different Speeds.
Yes
|
432 scores
|
365 scores
|
426 scores
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptance of Injection Pain After Injection at Different Speeds.
No
|
59 scores
|
44 scores
|
66 scores
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 minute (±30 seconds) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.
Yes
|
390 scores
|
978 scores
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.
No
|
101 scores
|
87 scores
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutes (±30sec) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.
Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 300 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
1.4 mcL
Standard Deviation 2.9
|
0.8 mcL
Standard Deviation 1.9
|
0.5 mcL
Standard Deviation 1.6
|
0.4 mcL
Standard Deviation 1.3
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
No summary statistics done for this combination
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 450 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
0.6 mcL
Standard Deviation 1.1
|
1.1 mcL
Standard Deviation 4.6
|
0.5 mcL
Standard Deviation 1.3
|
0.9 mcL
Standard Deviation 2.7
|
NA mcL
Standard Deviation NA
No summary statistics done for this combination
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
Needle insertion
|
0.0 mcL
Standard Deviation 0.1
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 150 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
2.3 mcL
Standard Deviation 5.1
|
0.9 mcL
Standard Deviation 1.9
|
0.5 mcL
Standard Deviation 1.4
|
0.6 mcL
Standard Deviation 1.8
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
No summary statistics done for this combination
|
—
|
SECONDARY outcome
Timeframe: 2 minutes (±30sec) after each injectionPopulation: All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.
Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
Outcome measures
| Measure |
Thighs: Injection Region-5 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
|
Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion
n=82 Participants
Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
|
Injection Volume 1600 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 1200 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 800 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Volume 400 μL
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 450 μL/s
n=82 Participants
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 300 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
Injection Speed at 150 μL/s
Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
|
|---|---|---|---|---|---|---|---|---|---|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
Needle insertion
|
0.8 mcL
Standard Deviation 5.6
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 150 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
5.6 mcL
Standard Deviation 8.6
|
NA mcL
Standard Deviation NA
Not administered
|
1.0 mcL
Standard Deviation 3.1
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
No summary statistics done for this combination.
|
—
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 300 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
2.3 mcL
Standard Deviation 7.9
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Summary statistics is same as presented in Injection speed at 300 μL/s x Injection Volume 800 μL.
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
—
|
|
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
Injection speed at 450 μL/s
|
NA mcL
Standard Deviation NA
Not administered
|
2.5 mcL
Standard Deviation 4.6
|
NA mcL
Standard Deviation NA
Not administered
|
1.6 mcL
Standard Deviation 4.9
|
NA mcL
Standard Deviation NA
No summary statistics done for this combination.
|
NA mcL
Standard Deviation NA
Not administered
|
NA mcL
Standard Deviation NA
Not administered
|
—
|
—
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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 Novo Nordisk reserves the right to defer the release of data until specified milestones are reached, for example when the clinical trial report is available. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER