Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Recruiting
Phase 2Phase 3Interventional Study
Pain, Postoperative
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
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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
Trial Locations
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Status
Eligibility 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 inpati…
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
Contacts
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