Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
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|ClinicalTrials.gov Identifier: NCT01977937|
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
The purpose of this study is to evaluate the patient experience when using gabapentin with other pain control medications after posterior spinal fusion surgery for scoliosis in adolescents. These results will be compared to patients who underwent the same procedure during the study period and received the same standardized pain control regimen excluding gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side effects including nausea, sedation and urinary retention (inability to empty one's bladder) will also be recorded.The null hypotheses are as follows:
- There is no significant difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.
- There is no significant difference in the amount of opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Gabapentin 250mg/5mL NDC:59762-5025-01 Drug: Simple Syrup||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-operative Opioid Use and Patient Satisfaction|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
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.
Drug: Gabapentin 250mg/5mL NDC:59762-5025-01
Placebo Comparator: 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.
Drug: Simple Syrup
- Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients. [ Time Frame: 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.
- Opiate Usage in the Gabapentin Group Versus Control. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977937
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Matthew Halsey, MD||Oregon Health and Science University|