Pain, Postoperative
Conditions
Keywords
thoracic surgery, cardiac surgery via a sternotomy or thoracotomy
Brief summary
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
Detailed description
This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment. 60 subjects will be randomized in a 1:1 ratio to either: * Gabapentin treatment group * Placebo - control group We aim to understand the impact that gabapentin use peri and post operatively has on: 1. opioid use based of IV morphine 2. pain scores 3. opioid related complications such as withdrawal 4. effects on the level of sedation 5. Possible adverse effects associated with use of gabapentin 6. Time to extubating The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.
Interventions
DRUGGabapentin
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
OTHERPlacebo
Control Arm
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
Intervention model description
Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of pain medication needed. | 7 days post-operative or until discharge, whichever came first | Amount of pain medication needed after surgery |
Countries
United States
Outcome results
None listed