Pain, PostoperativePhase 2/3NCT04724252
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
A Phase 2/3 study testing Gabapentin in people with Pain, Postoperative, run by University of California, Davis at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Michaela Canova, BA, 916-734-1202, mecanova@health.ucdavis.edu
Daniel Neyshloss, BS, 916-734-1202, dbneyshloss@health.ucdavis.edu
About this study
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
Read the 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:
- opioid use based of IV morphine
- pain scores
- opioid related complications such as withdrawal
- effects on the level of sedation
- Possible adverse effects associated with use of gabapentin
- 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.
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin, Placebo
- Keywords
- thoracic surgery, cardiac surgery via a sternotomy or thoracotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
PlaceboOther
Control Arm
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin Treatment | Active comparator | Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose. Receives: Drug: Gabapentin |
| Control Group | Placebo comparator | Given placebo which coincides with the active treatment group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pain medication needed.
Amount of pain medication needed after surgery
Measured: 7 days post-operative or until discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start23 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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):
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724252
- Sponsor's protocol ID
- 1571754
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
- ClinicalTrials.gov ID
- NCT04724252
- Acronym / sponsor ID
- 1571754
- Conditions
- Pain, Postoperative
- Keywords
- thoracic surgery, cardiac surgery via a sternotomy or thoracotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- opioid use based of IV morphine
- pain scores
- opioid related complications such as withdrawal
- effects on the level of sedation
- Possible adverse effects associated with use of gabapentin
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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):
| Arm | Type | Receives |
|---|---|---|
| Gabapentin Treatment | Active comparator | Drug: GabapentinGiven at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose. |
| Control Group | Placebo comparator | Other: PlaceboGiven placebo which coincides with the active treatment group |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinDetermine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery. | Drug | Gabapentin Treatment |
| PlaceboControl Arm | Other | Control Group |
Primary outcome
Amount of pain medication needed.
Time frame: 7 days post-operative or until discharge, whichever came first
Amount of pain medication needed after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gabapentin in people with Pain, Postoperative, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of pain medication needed. (time frame: 7 days post-operative or until discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.