NCT02926573 · OUTCOME
Mean Pain With Swallowing Score as Measured by VAS
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients · Source last updated 2018-08-08
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mm
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline through post operative day 3
What was measured
* Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.
* Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain
Groups in this outcome
Gabapentin
Gabapentin liquid by mouth or per Tube 300mg twice a day
Placebo
Placebo liquid by mouth or Per Tube twice a day
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Gabapentin | 42 |
|---|
| Placebo | 43 |
|---|
Reported measurements
Post-operative Day 1 7AM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 49 | 32.3 | Not reported | Not reported | Not reported |
|---|
| Placebo | 48 | 30.7 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 1 10AM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 46 | 33.8 | Not reported | Not reported | Not reported |
|---|
| Placebo | 51 | 31.3 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 1 7PM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 41 | 29.2 | Not reported | Not reported | Not reported |
|---|
| Placebo | 52 | 28.5 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 2 7AM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 41 | 30.1 | Not reported | Not reported | Not reported |
|---|
| Placebo | 48 | 28.9 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 2 10AM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 37 | 29.5 | Not reported | Not reported | Not reported |
|---|
| Placebo | 45 | 29.8 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 2 7PM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 40 | 29.3 | Not reported | Not reported | Not reported |
|---|
| Placebo | 56 | 29.3 | Not reported | Not reported | Not reported |
|---|
Post-operative Day 3 7AM
Values in mm · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gabapentin | 35 | 28.0 | Not reported | Not reported | Not reported |
|---|
| Placebo | 52 | 30.5 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -14.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.9
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -1.4
- ci Lower Limit
- -8.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.2
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 5.3
- ci Lower Limit
- -2.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.2
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 10.9
- ci Lower Limit
- -6.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.7
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.
- param Type
- Mean Difference (Final Values)
- param Value
- 7.0
- ci Lower Limit
- -6.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.3
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 8.0
- ci Lower Limit
- -0.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.7
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 15.7
- ci Lower Limit
- 0.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.4
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 16.7
Complete source fields
- analyses
- ci Lower Limit
- -14.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.9
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -1.4
- ci Lower Limit
- -8.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.2
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 5.3
- ci Lower Limit
- -2.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.2
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 10.9
- ci Lower Limit
- -6.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.7
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.
- param Type
- Mean Difference (Final Values)
- param Value
- 7.0
- ci Lower Limit
- -6.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.3
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 8.0
- ci Lower Limit
- -0.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 31.7
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 15.7
- ci Lower Limit
- 0.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.4
- estimate Comment
- This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 16.7
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 32.3
- value
- 49
- group Id
- OG001
- spread
- 30.7
- value
- 48
- title
- Post-operative Day 1 7AM
- categories
- measurements
- group Id
- OG000
- spread
- 33.8
- value
- 46
- group Id
- OG001
- spread
- 31.3
- value
- 51
- title
- Post-operative Day 1 10AM
- categories
- measurements
- group Id
- OG000
- spread
- 29.2
- value
- 41
- group Id
- OG001
- spread
- 28.5
- value
- 52
- title
- Post-operative Day 1 7PM
- categories
- measurements
- group Id
- OG000
- spread
- 30.1
- value
- 41
- group Id
- OG001
- spread
- 28.9
- value
- 48
- title
- Post-operative Day 2 7AM
- categories
- measurements
- group Id
- OG000
- spread
- 29.5
- value
- 37
- group Id
- OG001
- spread
- 29.8
- value
- 45
- title
- Post-operative Day 2 10AM
- categories
- measurements
- group Id
- OG000
- spread
- 29.3
- value
- 40
- group Id
- OG001
- spread
- 29.3
- value
- 56
- title
- Post-operative Day 2 7PM
- categories
- measurements
- group Id
- OG000
- spread
- 28.0
- value
- 35
- group Id
- OG001
- spread
- 30.5
- value
- 52
- title
- Post-operative Day 3 7AM
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- * Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.
* Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain
- dispersion Type
- Standard Deviation
- groups
- description
- Gabapentin liquid by mouth or per Tube 300mg twice a day
- id
- OG000
- title
- Gabapentin
- description
- Placebo liquid by mouth or Per Tube twice a day
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline through post operative day 3
- title
- Mean Pain With Swallowing Score as Measured by VAS
- type
- SECONDARY
- unit Of Measure
- mm
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Preserved source evidence · Not medical advice
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