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Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NRS for pain intensity score comparing gabapentin and placebo groups | Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS > 4/10 at the time of the survey will be considered positive for CPSP. | Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively |
| Change in FDI score comparing gabapentin and placebo groups | The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60). | Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo | Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Hartzell, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
Data will become available immediately following publication and ending 5 years following article publication.
Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Other | 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. |
|
| Postoperative period up to 1 month |
| Time to ambulation in patients receiving gabapentin versus placebo | Time to ambulation will be recorded. | Postoperative period up to 1 month |
| First oral intake in patients receiving gabapentin versus placebo | Time to first oral intake will be recorded. | Postoperative period up to 1 month |
| Time to discharge in each group in patients receiving gabapentin versus standard of care | Time to discharge will be recorded. | Postoperative period up to 1 month |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |