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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

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ClinicalTrials.gov Identifier: NCT04724252
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Gabapentin Other: Placebo Phase 2 Phase 3

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:

  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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
Primary Purpose: Treatment
Official Title: Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Actual Study Start Date : August 23, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gabapentin Treatment
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.
 Drug: Gabapentin
Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
Placebo Comparator: Control Group
Given placebo which coincides with the active treatment group
 Other: Placebo
Control Arm


Outcome Measures
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Primary Outcome Measures :
  1. Amount of pain medication needed. [ Time Frame: 7 days post-operative or until discharge, whichever came first ]
    Amount of pain medication needed after surgery


Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724252


Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Carly Davis, BS    916-453-2132    cjddavis@ucdavis.edu   
Contact: Mary Beth Lawless, MS, RN    916-453-2133    mblawless@ucdavis.edu   
Principal Investigator: Gary Raff, MD         
Sponsors and Collaborators
University of California, Davis
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04724252    
Other Study ID Numbers: 1571754
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Davis:
thoracic surgery
cardiac surgery via a sternotomy or thoracotomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents