What this study is
The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.
We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin
What's being tested
- Gabapentin
Intervention · DRUG
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
- Placebo
Intervention · OTHER
Control Arm
Study details
- Sponsor
- University of California, Davis
- Conditions
- Pain, Postoperative
- Enrolling
- 60 people
- Starts
- 2021-08-23
- Est. completion
- 2027-12-31
- Design
- Double-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age newborn to < 18 years.
- Gestational age to be minimum 38 weeks.
- Undergo cardiac surgery via a sternotomy or thoracotomy. OR Any Thoracic Surgery OR Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
- Surgery will result in an inpatient stay of at least 48 hours.
You can't join if
- Use of opioids within 30 days prior to study entry.
- Renal Failure as defined by RIFLE Criteria.
- History of seizures requiring active treatment.
- History of chronic pain treated medically.
- Diagnosis of Autism.
- Unable to tolerate enteral medications.
- Hematology/Oncology patients.
- Parents/legal guardians unable to consent.
- Participation in another clinical study presently or within the last 30 days
- Pregnancy
- Prisoners
- Patient undergoing nuss procedure with cryoablation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUC Davis Medical Center
Sacramento, California, United States
- Michaela Canova, BA · Contact916-734-1202mecanova@health.ucdavis.edu
- Daniel Neyshloss, BS · Contact916-734-1202dbneyshloss@health.ucdavis.edu
- Gary Raff, MD · Principal investigator
Recruiting
Study team
Sponsor
University of California, Davis
Study ID 1571754
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.