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
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|
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:
- opioid use based of IV morphine
- pain scores
- opioid related complications such as withdrawal
- effects on the level of sedation
- Possible adverse effects associated with use of gabapentin
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
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.
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
- Amount of pain medication needed. [ Time Frame: 7 days post-operative or until discharge, whichever came first ]Amount of pain medication needed after surgery
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
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Carly Davis, BS 916-453-2132 email@example.com|
|Contact: Mary Beth Lawless, MS, RN 916-453-2133 firstname.lastname@example.org|
|Principal Investigator: Gary Raff, MD|