Trial Outcomes & Findings for Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin (NCT NCT01977937)

NCT ID: NCT01977937

Last Updated: 2019-06-12

Results Overview

Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of "no pain" and "worst pain imaginable." Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the "no pain end on the left up to 10.0 at the "worst pain imaginable" on the right). Lower pain scores on the VAS scale are considered a better outcome. The numbers seen in the outcome measure data table below represent an average of the total postoperative VAS scores recorded for each patient from each arm for the duration of their hospital stay.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: five days
• Results posted on: 2019-06-12

Participant Flow

Participant milestones

Measure	Gabapentin Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup
Overall Study STARTED	27	28
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Gabapentin Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Gabapentin n=24 Participants Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup n=26 Participants Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup	Total n=50 Participants Total of all reporting groups
Age, Continuous	14.8 years STANDARD_DEVIATION 2.0 • n=24 Participants	14.2 years STANDARD_DEVIATION 2.1 • n=26 Participants	14.5 years STANDARD_DEVIATION 2.0 • n=50 Participants
Sex: Female, Male Female	19 Participants n=24 Participants	19 Participants n=26 Participants	38 Participants n=50 Participants
Sex: Female, Male Male	5 Participants n=24 Participants	7 Participants n=26 Participants	12 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 participants n=24 Participants	26 participants n=26 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: five days

Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of "no pain" and "worst pain imaginable." Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the "no pain end on the left up to 10.0 at the "worst pain imaginable" on the right). Lower pain scores on the VAS scale are considered a better outcome. The numbers seen in the outcome measure data table below represent an average of the total postoperative VAS scores recorded for each patient from each arm for the duration of their hospital stay.

Outcome measures

Measure	Gabapentin n=24 Participants Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup n=26 Participants Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup
Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients.	2.46 pain score on a scale Standard Deviation 1.74	3.46 pain score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Five Days

Total the amount of Hydromorphone and Oxycodone used in milligrams per kilogram in each patient post-operatively, convert this amount to morphine equivalents, and determine if there is a significant difference between the Gabapentin versus Placebo group.

Outcome measures

Measure	Gabapentin n=24 Participants Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup n=26 Participants Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup
Opiate Usage in the Gabapentin Group Versus Control.	3.58 morphine equivalents mg per kg Standard Deviation 1.82	5.33 morphine equivalents mg per kg Standard Deviation 3.20

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Simple Syrup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gabapentin n=24 participants at risk Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. Gabapentin	Simple Syrup n=26 participants at risk Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital. Simple Syrup
Gastrointestinal disorders Emesis	4.2% 1/24 • Number of events 1 • Adverse event data was collected over the time period that patients spent in the hospital during their procedure (operative day through discharge day). Average hospital stay was 4.5 days with a standard deviation of 0.7 days for the gabapentin arm and 0.9 days for the placebo arm.	0.00% 0/26 • Adverse event data was collected over the time period that patients spent in the hospital during their procedure (operative day through discharge day). Average hospital stay was 4.5 days with a standard deviation of 0.7 days for the gabapentin arm and 0.9 days for the placebo arm.

Additional Information

Dr Elizabeth Pedigo

OHSU

Phone: 5039705211

Email: pedigo@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place