Using gabapentin to reduce opioid use in children after thoracic surgery
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
This study is testing if gabapentin can help reduce the amount of pain medication kids need after having thoracic surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04724252 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of gabapentin in reducing the need for narcotics in children undergoing thoracic surgery. It is a double-blind, placebo-controlled, randomized study involving 60 subjects who will be assigned to either a gabapentin treatment group or a placebo control group. The study aims to assess various outcomes, including opioid use, pain scores, and potential complications related to opioid use and gabapentin. Participants will be monitored for 7 days or until discharge from the hospital.
Who should consider this trial
Good fit: Ideal candidates are children aged newborn to under 18 years undergoing thoracic surgery with an expected inpatient stay of at least 48 hours.
Not a fit: Patients with a history of seizures, chronic pain, or recent opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce opioid consumption in pediatric patients post-surgery, leading to improved recovery and fewer opioid-related complications.
How similar studies have performed: Other studies have shown promising results with gabapentin in reducing opioid use, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age newborn to \< 18 years. 2. Gestational age to be minimum 38 weeks. 3. Undergo cardiac surgery via a sternotomy or thoracotomy. OR Any Thoracic Surgery OR Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS). 4. Surgery will result in an inpatient stay of at least 48 hours. Exclusion Criteria: 1. Use of opioids within 30 days prior to study entry. 2. Renal Failure as defined by RIFLE Criteria. 3. History of seizures requiring active treatment. 4. History of chronic pain treated medically. 5. Diagnosis of Autism. 6. Unable to tolerate enteral medications. 7. Hematology/Oncology patients. 8. Parents/legal guardians unable to consent. 9. Participation in another clinical study presently or within the last 30 days 10. Pregnancy 11. Prisoners 12. Patient undergoing nuss procedure with cryoablation
Where this trial is running
Sacramento, California
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.