Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Pain, Postoperative Clinical Trial

Official title:

Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724252
• Other study ID #: 1571754
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 23, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

4. Any Thoracic Surgery

5. Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).

6. 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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of pain medication needed.	Amount of pain medication needed after surgery	7 days post-operative or until discharge, whichever came first

External Links

•   Learn more or sign up for the study here!