Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pain Postoperative
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Younger than 17 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT04724252
- Collaborators
- Not Provided
- Investigators
- Not Provided
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