Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gabapentin, Placebo.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Gabapentin
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery. - Other Placebo
Control Arm
Primary outcome measures
- Amount of pain medication needed. [Time frame: 7 days post-operative or until discharge, whichever came first]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC Davis Medical Center — Sacramento
Identifiers
NCT: NCT04724252 · 1571754