Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

University of California (UC) Davis

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Gabapentin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04724252

1571754

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age newborn to < 18 years.
2. Gestational age to be minimum 38 weeks.
3. Undergo cardiac surgery via a sternotomy or thoracotomy. OR Any Thoracic Surgery OR Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
4. Surgery will result in an inpatient stay of at least 48 hours.

Exclusion criteria

1. Use of opioids within 30 days prior to study entry.
2. Renal Failure as defined by RIFLE Criteria.
3. History of seizures requiring active treatment.
4. History of chronic pain treated medically.
5. Diagnosis of Autism.
6. Unable to tolerate enteral medications.
7. Hematology/Oncology patients.
8. Parents/legal guardians unable to consent.
9. Participation in another clinical study presently or within the last 30 days
10. Pregnancy
11. Prisoners
12. Patient undergoing nuss procedure with cryoablation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Gabapentin Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Control Group

Placebo Comparator group

Description:

Given placebo which coincides with the active treatment group

Treatment:

Other: Placebo