Gabapentin and Chronic Post Surgical Pain (CPSP)

Emory University

Status and phase: Withdrawn; Phase 3

Conditions: Pain, Postoperative; Scoliosis Idiopathic

Treatments: Drug: Gabapentin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03867240

IRB00106205

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo