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New treatment option for Pain, Postoperative
Official title Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
ClinicalTrials.gov ID: NCT04724252
What this study is testing
What is Gabapentin?
Gabapentin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain, postoperative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join 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...
- Surgery will result in an inpatient stay of at least 48 hours.
You likely 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.
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.