Acute Lymphoblastic Leukemia, Neuropathic Pain, Neuropathy
Conditions
Keywords
Acute Lymphoblastic Leukemia, Neuropathy, Neuropathic Pain, Vincristine, TOTAL XVI Protocol
Brief summary
Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated as per TOTXVI protocol), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.
Detailed description
Patients with ALL on Total XVI ((or for those being treated as per TOTXVI protocol) who experience NP/PN after specific doses of vincristine are eligible to enroll in the study as soon as the diagnosis of NP/PN related to VCR is established. The qualifying doses of vincristine have been selected because they fall in the schedule of weekly vincristine doses as per Total XVI, and 2 additional weekly vincristine doses are anticipated according to the protocol. Participants will be randomized to receive gabapentin or placebo upon enrollment. Morphine will be available to both groups as needed for pain at any time on the study. At the time of enrollment, and daily thereafter until completion of the study drug, data will be collected for pain assessment, and the daily dose of oral morphine used will be collected. Data regarding the pain type, quality, and location, as well as treatments used to manage pain will be assessed on a daily basis for the diagnostic event and for the period following the next two administrations of VCR treated with the study drug. Primary Objective: To assess the analgesic efficacy of gabapentin in controlling VCR-related NP/PN in participants with ALL, by comparing the morphine daily dose (mg/kg/day) used to control NP/PN as a primary or a rescue regimen in the gabapentin vs. placebo groups. Secondary Objective: To compare the pain scores in the gabapentin and placebo groups as recorded by pain score right now and pain score average for previous 24 hours.
Interventions
DRUGgabapentin
Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation.
DRUGplacebo
Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Participant is enrolled on Total XVI or who are being treated as per TOTXVI protocol * Participant is 1 year of age or older * Participant has symptoms of NP/PN with onset no more than 7 days after one of the following vincristine doses ± 3 days: protocol week 1, week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II). * Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the Total XVI protocol (or for those being treated as per TOTXVI protocol) while on study drug (i.e. no known dosage reductions or planned missed doses). Participant is able and willing to take oral medications.
Exclusion criteria
* Previous participation in this study * Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously. * Pregnancy. Female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. Male patients with reproductive potential will be counseled not to procreate during the study. * Impaired renal function: decreased eGFR (\<60ml/min/1.73m\^2 as estimated by the revised Schwartz equation) * Participant has allergy or other contraindication for either morphine or gabapentin therapy. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Daily beginning day 1 for a maximum of 21 days. | The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Right Now | Daily beginning day 1 through a maximum of 21 days. | A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. |
| Pain Score During the Previous 24 Hours | Daily beginning day 1 through a maximum of 21 days | A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated.Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. |
Countries
United States
Participant flow
Recruitment details
51 participants were enrolled and screened between January 2012 and October 2016.
Pre-assignment details
The remaining 51 participants were randomized to take gabapentin or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Active treatment arm
gabapentin: Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation. | 25 |
| Placebo Placebo arm
placebo: Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment. | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal prior to treatment | 0 | 2 |
Baseline characteristics
| Characteristic | Gabapentin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 7.88 years STANDARD_DEVIATION 5.69 | 7.08 years STANDARD_DEVIATION 3.9 | 7.48 years STANDARD_DEVIATION 4.83 |
| baseline pain score last 24 hours | 4.08 units on a scale STANDARD_DEVIATION 1.66 | 4.31 units on a scale STANDARD_DEVIATION 1.76 | 4.20 units on a scale STANDARD_DEVIATION 1.7 |
| Daily pain score right now | 3.12 units on a scale STANDARD_DEVIATION 1.86 | 3.58 units on a scale STANDARD_DEVIATION 1.42 | 3.35 units on a scale STANDARD_DEVIATION 1.65 |
| Race/Ethnicity, Customized Baseline Measures Asian and White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Baseline Measures Black | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Baseline Measures Black and White | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Baseline Measures White | 23 Participants | 21 Participants | 44 Participants |
| Region of Enrollment United States | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 5 / 25 | 5 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Daily Total Dose of Oral Morphine (mg/kg/Day).
The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar.
Time frame: Daily beginning day 1 for a maximum of 21 days.
Population: The daily morphine dosage will be modeled as longitudinal observations with treatment (gabapentin vs. placebo) group, and if necessary, other clinical factors such as age category for pain assessment (0-3yr, 4-7yr, \>7yr), baseline pain score, and ALL risk classification, as explanatory factors, using repeated measure linear models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 6 | 0.45679 mg/kg/day | Standard Deviation 0.4545 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 1 | 0.38267 mg/kg/day | Standard Deviation 0.28921 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 2 | 0.43685 mg/kg/day | Standard Deviation 0.33788 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 3 | 0.37281 mg/kg/day | Standard Deviation 0.32935 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 4 | 0.40384 mg/kg/day | Standard Deviation 0.32469 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 5 | 0.37662 mg/kg/day | Standard Deviation 0.31263 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 7 | 0.50961 mg/kg/day | Standard Deviation 0.43643 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 8 | 0.50767 mg/kg/day | Standard Deviation 0.5357 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 9 | 0.49234 mg/kg/day | Standard Deviation 0.33366 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 10 | 0.44392 mg/kg/day | Standard Deviation 0.37244 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 11 | 0.50981 mg/kg/day | Standard Deviation 0.67516 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 12 | 0.57798 mg/kg/day | Standard Deviation 0.51346 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 13 | 0.68183 mg/kg/day | Standard Deviation 0.51698 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 14 | 0.53028 mg/kg/day | Standard Deviation 0.5787 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 15 | 0.55939 mg/kg/day | Standard Deviation 0.69755 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 16 | 0.37643 mg/kg/day | Standard Deviation 0.37817 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 17 | 0.38837 mg/kg/day | Standard Deviation 0.3019 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 18 | 0.65013 mg/kg/day | Standard Deviation 0.96603 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 19 | 0.84586 mg/kg/day | Standard Deviation 1.08656 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 20 | 1.12358 mg/kg/day | Standard Deviation 1.3779 |
| Gabapentin | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 21 | 0.14981 mg/kg/day | — |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 11 | 0.29937 mg/kg/day | Standard Deviation 0.14111 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 1 | 0.27433 mg/kg/day | Standard Deviation 0.19299 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 16 | 0.48481 mg/kg/day | Standard Deviation 0.37075 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 2 | 0.31816 mg/kg/day | Standard Deviation 0.16012 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 12 | 0.40090 mg/kg/day | Standard Deviation 0.21956 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 3 | 0.27961 mg/kg/day | Standard Deviation 0.18509 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 20 | 0.15108 mg/kg/day | — |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 4 | 0.35343 mg/kg/day | Standard Deviation 0.18688 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 13 | 0.45933 mg/kg/day | Standard Deviation 0.32854 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 5 | 0.37920 mg/kg/day | Standard Deviation 0.22471 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 6 | 0.43972 mg/kg/day | Standard Deviation 0.19838 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 17 | 0.54960 mg/kg/day | Standard Deviation 0.47579 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 7 | 0.37181 mg/kg/day | Standard Deviation 0.22883 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 14 | 0.34957 mg/kg/day | Standard Deviation 0.1546 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 8 | 0.38188 mg/kg/day | Standard Deviation 0.28251 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 19 | 0.14123 mg/kg/day | Standard Deviation 0.0074 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 9 | 0.34524 mg/kg/day | Standard Deviation 0.20164 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 15 | 0.36731 mg/kg/day | Standard Deviation 0.2317 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 10 | 0.34660 mg/kg/day | Standard Deviation 0.15843 |
| Placebo | Daily Total Dose of Oral Morphine (mg/kg/Day). | Day 18 | 0.13605 mg/kg/day | — |
Secondary
Pain Score During the Previous 24 Hours
A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated.Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.
Time frame: Daily beginning day 1 through a maximum of 21 days
Population: There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 20 and 21.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Pain Score During the Previous 24 Hours | Day 4 | 2.80000 score on a scale 0-10 | Standard Deviation 2.43242 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 12 | 2.41667 score on a scale 0-10 | Standard Deviation 2.43018 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 7 | 2.96000 score on a scale 0-10 | Standard Deviation 2.22636 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 13 | 2.50000 score on a scale 0-10 | Standard Deviation 2.20671 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 3 | 3.08000 score on a scale 0-10 | Standard Deviation 2.28983 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 14 | 2.60870 score on a scale 0-10 | Standard Deviation 2.27115 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 8 | 2.76000 score on a scale 0-10 | Standard Deviation 2.24128 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 15 | 2.54545 score on a scale 0-10 | Standard Deviation 2.15423 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 5 | 2.80000 score on a scale 0-10 | Standard Deviation 2.61406 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 16 | 2.23529 score on a scale 0-10 | Standard Deviation 1.82104 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 9 | 2.16000 score on a scale 0-10 | Standard Deviation 2.21133 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 17 | 1.40000 score on a scale 0-10 | Standard Deviation 1.59463 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 2 | 3.16000 score on a scale 0-10 | Standard Deviation 2.37487 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 18 | 2.36364 score on a scale 0-10 | Standard Deviation 3.00908 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 10 | 2.16000 score on a scale 0-10 | Standard Deviation 2.2487 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 19 | 1.40000 score on a scale 0-10 | Standard Deviation 1.34164 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 6 | 2.28000 score on a scale 0-10 | Standard Deviation 1.92614 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 20 | 2.33333 score on a scale 0-10 | Standard Deviation 0.57735 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 11 | 2.32000 score on a scale 0-10 | Standard Deviation 2.05589 |
| Gabapentin | Pain Score During the Previous 24 Hours | Day 1 | 3.48000 score on a scale 0-10 | Standard Deviation 2.502 |
| Placebo | Pain Score During the Previous 24 Hours | Day 20 | 0 score on a scale 0-10 | Standard Deviation 0 |
| Placebo | Pain Score During the Previous 24 Hours | Day 21 | 0 score on a scale 0-10 | Standard Deviation 0 |
| Placebo | Pain Score During the Previous 24 Hours | Day 1 | 3.41667 score on a scale 0-10 | Standard Deviation 2.39414 |
| Placebo | Pain Score During the Previous 24 Hours | Day 2 | 2.20833 score on a scale 0-10 | Standard Deviation 2.14637 |
| Placebo | Pain Score During the Previous 24 Hours | Day 3 | 1.87500 score on a scale 0-10 | Standard Deviation 1.87228 |
| Placebo | Pain Score During the Previous 24 Hours | Day 4 | 2.12500 score on a scale 0-10 | Standard Deviation 2.64267 |
| Placebo | Pain Score During the Previous 24 Hours | Day 5 | 2.00000 score on a scale 0-10 | Standard Deviation 2.14679 |
| Placebo | Pain Score During the Previous 24 Hours | Day 6 | 1.91667 score on a scale 0-10 | Standard Deviation 2.20507 |
| Placebo | Pain Score During the Previous 24 Hours | Day 7 | 1.16667 score on a scale 0-10 | Standard Deviation 1.60615 |
| Placebo | Pain Score During the Previous 24 Hours | Day 8 | 1.69565 score on a scale 0-10 | Standard Deviation 1.91726 |
| Placebo | Pain Score During the Previous 24 Hours | Day 9 | 1.34783 score on a scale 0-10 | Standard Deviation 1.74795 |
| Placebo | Pain Score During the Previous 24 Hours | Day 10 | 1.43478 score on a scale 0-10 | Standard Deviation 1.64665 |
| Placebo | Pain Score During the Previous 24 Hours | Day 11 | 1.56522 score on a scale 0-10 | Standard Deviation 1.67403 |
| Placebo | Pain Score During the Previous 24 Hours | Day 12 | 1.52174 score on a scale 0-10 | Standard Deviation 1.90381 |
| Placebo | Pain Score During the Previous 24 Hours | Day 13 | 1.60870 score on a scale 0-10 | Standard Deviation 1.85225 |
| Placebo | Pain Score During the Previous 24 Hours | Day 14 | 1.56522 score on a scale 0-10 | Standard Deviation 1.64665 |
| Placebo | Pain Score During the Previous 24 Hours | Day 15 | 1.39130 score on a scale 0-10 | Standard Deviation 1.67167 |
| Placebo | Pain Score During the Previous 24 Hours | Day 16 | 1.56250 score on a scale 0-10 | Standard Deviation 1.8246 |
| Placebo | Pain Score During the Previous 24 Hours | Day 17 | 1.92857 score on a scale 0-10 | Standard Deviation 2.01778 |
| Placebo | Pain Score During the Previous 24 Hours | Day 18 | 1.00000 score on a scale 0-10 | Standard Deviation 1.65145 |
| Placebo | Pain Score During the Previous 24 Hours | Day 19 | 0.40000 score on a scale 0-10 | Standard Deviation 0.89443 |
Secondary
Pain Scores Right Now
A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.
Time frame: Daily beginning day 1 through a maximum of 21 days.
Population: There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 19, 20 and 21.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Pain Scores Right Now | Day 19 | 1.00000 score on a scale 0-10 | Standard Deviation 1.41421 |
| Gabapentin | Pain Scores Right Now | Day 8 | 1.32000 score on a scale 0-10 | Standard Deviation 1.90875 |
| Gabapentin | Pain Scores Right Now | Day 3 | 1.88000 score on a scale 0-10 | Standard Deviation 2.6032 |
| Gabapentin | Pain Scores Right Now | Day 9 | 1.48000 score on a scale 0-10 | Standard Deviation 2.06398 |
| Gabapentin | Pain Scores Right Now | Day 18 | 1.45455 score on a scale 0-10 | Standard Deviation 2.54416 |
| Gabapentin | Pain Scores Right Now | Day 10 | 1.16000 score on a scale 0-10 | Standard Deviation 1.65025 |
| Gabapentin | Pain Scores Right Now | Day 4 | 1.92000 score on a scale 0-10 | Standard Deviation 2.64449 |
| Gabapentin | Pain Scores Right Now | Day 11 | 1.16000 score on a scale 0-10 | Standard Deviation 1.90788 |
| Gabapentin | Pain Scores Right Now | Day 1 | 1.64000 score on a scale 0-10 | Standard Deviation 1.89033 |
| Gabapentin | Pain Scores Right Now | Day 12 | 1.21739 score on a scale 0-10 | Standard Deviation 1.88189 |
| Gabapentin | Pain Scores Right Now | Day 5 | 1.64000 score on a scale 0-10 | Standard Deviation 1.97653 |
| Gabapentin | Pain Scores Right Now | Day 13 | 1.04348 score on a scale 0-10 | Standard Deviation 1.46095 |
| Gabapentin | Pain Scores Right Now | Day 20 | 1.33333 score on a scale 0-10 | Standard Deviation 1.1547 |
| Gabapentin | Pain Scores Right Now | Day 14 | 0.82609 score on a scale 0-10 | Standard Deviation 1.11405 |
| Gabapentin | Pain Scores Right Now | Day 6 | 1.40000 score on a scale 0-10 | Standard Deviation 1.75594 |
| Gabapentin | Pain Scores Right Now | Day 2 | 2.00000 score on a scale 0-10 | Standard Deviation 2.19848 |
| Gabapentin | Pain Scores Right Now | Day 16 | 1.29412 score on a scale 0-10 | Standard Deviation 1.99263 |
| Gabapentin | Pain Scores Right Now | Day 7 | 2.20000 score on a scale 0-10 | Standard Deviation 2.17945 |
| Gabapentin | Pain Scores Right Now | Day 17 | 0.40000 score on a scale 0-10 | Standard Deviation 0.91026 |
| Gabapentin | Pain Scores Right Now | Day 15 | 0.90909 score on a scale 0-10 | Standard Deviation 1.63034 |
| Placebo | Pain Scores Right Now | Day 16 | 0.31250 score on a scale 0-10 | Standard Deviation 0.87321 |
| Placebo | Pain Scores Right Now | Day 17 | 0.21429 score on a scale 0-10 | Standard Deviation 0.80178 |
| Placebo | Pain Scores Right Now | Day 18 | 0.25000 score on a scale 0-10 | Standard Deviation 0.86603 |
| Placebo | Pain Scores Right Now | Day 19 | 0 score on a scale 0-10 | Standard Deviation 0 |
| Placebo | Pain Scores Right Now | Day 20 | 0 score on a scale 0-10 | Standard Deviation 0 |
| Placebo | Pain Scores Right Now | Day 21 | 0 score on a scale 0-10 | Standard Deviation 0 |
| Placebo | Pain Scores Right Now | Day 1 | 1.69565 score on a scale 0-10 | Standard Deviation 2.09837 |
| Placebo | Pain Scores Right Now | Day 2 | 1.16667 score on a scale 0-10 | Standard Deviation 1.57885 |
| Placebo | Pain Scores Right Now | Day 3 | 0.75000 score on a scale 0-10 | Standard Deviation 1.25974 |
| Placebo | Pain Scores Right Now | Day 4 | 0.83333 score on a scale 0-10 | Standard Deviation 1.30773 |
| Placebo | Pain Scores Right Now | Day 5 | 1.00000 score on a scale 0-10 | Standard Deviation 1.44463 |
| Placebo | Pain Scores Right Now | Day 6 | 0.79167 score on a scale 0-10 | Standard Deviation 1.38247 |
| Placebo | Pain Scores Right Now | Day 7 | 0.91667 score on a scale 0-10 | Standard Deviation 1.50121 |
| Placebo | Pain Scores Right Now | Day 8 | 0.56522 score on a scale 0-10 | Standard Deviation 1.23679 |
| Placebo | Pain Scores Right Now | Day 9 | 0.86957 score on a scale 0-10 | Standard Deviation 1.63219 |
| Placebo | Pain Scores Right Now | Day 10 | 0.39130 score on a scale 0-10 | Standard Deviation 0.83878 |
| Placebo | Pain Scores Right Now | Day 11 | 0.82609 score on a scale 0-10 | Standard Deviation 1.26678 |
| Placebo | Pain Scores Right Now | Day 12 | 1.00000 score on a scale 0-10 | Standard Deviation 1.50756 |
| Placebo | Pain Scores Right Now | Day 13 | 0.69565 score on a scale 0-10 | Standard Deviation 1.39593 |
| Placebo | Pain Scores Right Now | Day 14 | 0.52174 score on a scale 0-10 | Standard Deviation 1.23838 |
| Placebo | Pain Scores Right Now | Day 15 | 0.60870 score on a scale 0-10 | Standard Deviation 1.23359 |