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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)

Must not have

Parents/legal guardians unable to consent

History of seizures requiring active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days post-operative or until discharge, whichever came first

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My parents or legal guardians cannot give consent for me.

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I am currently being treated for seizures.

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My kidneys are not working properly.

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I cannot take medications by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days post-operative or until discharge, whichever came first

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 9Eligibility criteria met