Gabapentin and Chronic Post Surgical Pain

Study Purpose

The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Be aged 10-18 years at the time of surgery - 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 neuromuscular scoliosis and/or kyphosis - 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03867240
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Cheryl Hartzell, MD
Principal Investigator Affiliation	Emory University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain, Postoperative, Scoliosis Idiopathic

Additional Details

Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: 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.

Interventions

Drug: - 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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

Site Contact

Cheryl Hartzell, MD

[email protected]

404-785-6670

Clinical Trial Finder