Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-06-30
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gabapentin
Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.
Gabapentin
Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients \<50 kg and 200 mg for patients \> 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
Placebo
Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.
Placebo
Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.
Interventions
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Gabapentin
Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients \<50 kg and 200 mg for patients \> 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
Placebo
Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of idiopathic scoliosis and/or kyphosis
* Be undergoing elective posterior spinal fusion
* Have only mild systemic disease
Exclusion Criteria
* A diagnosis of chronic pain
* Used opioids in the past 6 months
* Developmental delay
* Liver or kidney disease
* Obstructive sleep apnea
* Body mass index \>40
* Be pregnant or breastfeeding
10 Years
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Cheryl Hartzell
Assistant Professor
Principal Investigators
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Cheryl Hartzell, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00106205
Identifier Type: -
Identifier Source: org_study_id
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