Trial Outcomes & Findings for Preoperative Gabapentin for Post-tonsillectomy Pain in Children (NCT NCT01707420)
NCT ID: NCT01707420
Last Updated: 2021-01-15
Results Overview
Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Up to 36 hours
Results posted on
2021-01-15
Participant Flow
Participant milestones
| Measure |
Placebo Group
Participants received placebo prior to tonsillectomy
|
Gabapentin Group
Participants received gabapentin prior to tonsillectomy
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo group
|
Gabapentin
n=18 Participants
Gabapentin
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Median age (years)
|
8.0 years
n=5 Participants
|
8.0 years
n=7 Participants
|
8.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 hoursPopulation: Healthy children aged 5 - 16 years old.
Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
Outcome measures
| Measure |
Placebo Group
n=18 Participants
Participants received placebo prior to tonsillectomy
|
Gabapentin Group
n=18 Participants
Participants received gabapentin prior to tonsillectomy
|
|---|---|---|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 1h
|
0.121 cumulative hydrocodone (mg/kg)
Standard Deviation 0.067
|
0.087 cumulative hydrocodone (mg/kg)
Standard Deviation 0.066
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 36h
|
0.228 cumulative hydrocodone (mg/kg)
Standard Deviation 0.106
|
0.224 cumulative hydrocodone (mg/kg)
Standard Deviation 0.165
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 24h
|
0.200 cumulative hydrocodone (mg/kg)
Standard Deviation 0.107
|
0.193 cumulative hydrocodone (mg/kg)
Standard Deviation 0.148
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 12h
|
0.171 cumulative hydrocodone (mg/kg)
Standard Deviation 0.079
|
0.165 cumulative hydrocodone (mg/kg)
Standard Deviation 0.116
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 8h
|
0.157 cumulative hydrocodone (mg/kg)
Standard Deviation 0.067
|
0.132 cumulative hydrocodone (mg/kg)
Standard Deviation 0.086
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 4h
|
0.135 cumulative hydrocodone (mg/kg)
Standard Deviation 0.060
|
0.109 cumulative hydrocodone (mg/kg)
Standard Deviation 0.066
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 1.5h
|
0.127 cumulative hydrocodone (mg/kg)
Standard Deviation 0.060
|
0.087 cumulative hydrocodone (mg/kg)
Standard Deviation 0.066
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 0.5h
|
0.107 cumulative hydrocodone (mg/kg)
Standard Deviation 0.077
|
0.068 cumulative hydrocodone (mg/kg)
Standard Deviation 0.046
|
|
Total Oral Analgesia Consumption
cumulative hydrocodone (mg/kg) at 0h
|
0.079 cumulative hydrocodone (mg/kg)
Standard Deviation 0.077
|
0.011 cumulative hydrocodone (mg/kg)
Standard Deviation 0.033
|
SECONDARY outcome
Timeframe: Up to 36 hoursSelf-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.
Outcome measures
| Measure |
Placebo Group
n=18 Participants
Participants received placebo prior to tonsillectomy
|
Gabapentin Group
n=18 Participants
Participants received gabapentin prior to tonsillectomy
|
|---|---|---|
|
Self-report Pain Score at Rest
0.5 hours
|
5.33 score on a scale
Standard Deviation 2.94
|
5.08 score on a scale
Standard Deviation 2.71
|
|
Self-report Pain Score at Rest
1.0 hours
|
4.33 score on a scale
Standard Deviation 2.74
|
5.80 score on a scale
Standard Deviation 4.02
|
|
Self-report Pain Score at Rest
1.5 hours
|
4.00 score on a scale
Standard Deviation 2.45
|
3.60 score on a scale
Standard Deviation 3.30
|
|
Self-report Pain Score at Rest
4 hours
|
3.46 score on a scale
Standard Deviation 2.70
|
3.00 score on a scale
Standard Deviation 2.28
|
|
Self-report Pain Score at Rest
8 hours
|
3.91 score on a scale
Standard Deviation 2.57
|
2.71 score on a scale
Standard Deviation 1.93
|
|
Self-report Pain Score at Rest
12 hours
|
2.69 score on a scale
Standard Deviation 2.34
|
4.20 score on a scale
Standard Deviation 2.35
|
|
Self-report Pain Score at Rest
24 hours
|
3.04 score on a scale
Standard Deviation 2.32
|
4.61 score on a scale
Standard Deviation 2.96
|
|
Self-report Pain Score at Rest
36 hours
|
1.95 score on a scale
Standard Deviation 1.74
|
4.00 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Up to 36 hoursSelf-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.
Outcome measures
| Measure |
Placebo Group
n=18 Participants
Participants received placebo prior to tonsillectomy
|
Gabapentin Group
n=18 Participants
Participants received gabapentin prior to tonsillectomy
|
|---|---|---|
|
Self-report Pain Score When Swallowing
0.5 Hours
|
6.47 score on a scale
Standard Deviation 3.16
|
5.42 score on a scale
Standard Deviation 3.37
|
|
Self-report Pain Score When Swallowing
1 Hours
|
4.78 score on a scale
Standard Deviation 2.95
|
6.00 score on a scale
Standard Deviation 3.65
|
|
Self-report Pain Score When Swallowing
1.5 Hours
|
5.40 score on a scale
Standard Deviation 3.71
|
5.50 score on a scale
Standard Deviation 2.99
|
|
Self-report Pain Score When Swallowing
4 Hours
|
4.30 score on a scale
Standard Deviation 1.64
|
4.27 score on a scale
Standard Deviation 3.44
|
|
Self-report Pain Score When Swallowing
8 Hours
|
5.30 score on a scale
Standard Deviation 2.67
|
4.00 score on a scale
Standard Deviation 2.18
|
|
Self-report Pain Score When Swallowing
12 Hours
|
3.86 score on a scale
Standard Deviation 2.27
|
4.80 score on a scale
Standard Deviation 2.86
|
|
Self-report Pain Score When Swallowing
24 Hours
|
5.46 score on a scale
Standard Deviation 2.88
|
5.65 score on a scale
Standard Deviation 3.64
|
|
Self-report Pain Score When Swallowing
36 Hours
|
3.70 score on a scale
Standard Deviation 2.41
|
5.13 score on a scale
Standard Deviation 2.47
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo group
|
Gabapentin
n=18 participants at risk
Gabapentin group
|
|---|---|---|
|
Surgical and medical procedures
Unplanned admission post tonsillectomy
|
5.6%
1/18 • Number of events 1
|
38.9%
7/18 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place