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Gabapentin for Postoperative Pain in Children

Phase 2 & 3
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age newborn to < 18 years
Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-operative or until discharge, whichever came first
Awards & highlights

Study Summary

This trial will give children gabapentin before and after surgery to see if it reduces the amount of narcotics they need.

Who is the study for?
This trial is for children from newborns up to under 18 years old who are undergoing thoracic surgery and will stay in the hospital for at least 48 hours. They must be born after a full-term pregnancy (at least 38 weeks). Children with autism, kidney failure, current participation in another study, opioid use within the last month, chronic pain treatment, active seizure disorders or those unable to take oral medication cannot join.Check my eligibility
What is being tested?
The trial is testing whether gabapentin can reduce the need for opioid painkillers after thoracic surgery in children. Participants will either receive gabapentin or a placebo during and after their operation to compare how much narcotic medication they'll need post-surgery.See study design
What are the potential side effects?
Gabapentin may cause side effects such as drowsiness, dizziness, headaches and nausea. In some cases it might also affect coordination or cause mood changes. It's important to monitor any reactions closely since this study involves children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old.
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I am scheduled for a chest surgery that is not related to my heart.
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I have had surgery in my chest area.
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My surgery will require me to stay in the hospital for at least 2 days.
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I will have heart surgery through an incision in my chest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post-operative or until discharge, whichever came first
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post-operative or until discharge, whichever came first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of pain medication needed.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Gabapentin TreatmentActive Control1 Intervention
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.
Group II: Control GroupPlacebo Group1 Intervention
Given placebo which coincides with the active treatment group

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,523 Total Patients Enrolled

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04724252 — Phase 2 & 3
Postoperative Pain Research Study Groups: Gabapentin Treatment, Control Group
Postoperative Pain Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT04724252 — Phase 2 & 3
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04724252 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers needed for this clinical trial?

"This clinical trial, which was initially posted on August 23rd, 2021 is currently seeking volunteers. The most recent update to the posting was made on January 25th, 2022."

Answered by AI

What are some common off-label indications for Gabapentin?

"Patients struggling with neuralgia, epileptic seizures, or postherpetic neuralgia may all find relief through gabapentin treatment."

Answered by AI

How many people are included in this research project?

"Yes, the trial is currently recruiting patients. According to the latest update on clinicaltrials.gov (1/25/2022), 60 participants are needed from 1 site."

Answered by AI

Can you give examples of other times when Gabapentin has been used as a medication?

"28 trials studying Gabapentin Treatment are ongoing, with 11 in Phase 3. 71 research locations are currently looking into this topic, though most of the significant studies come out of Columbus, Ohio."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Gary Raff 2021. "Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04724252.
All > Gabapentin
~12 spots leftby Dec 2024
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