Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04724252
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Gabapentin — DRUG
    Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
  • Placebo — OTHER
    Control Arm

Study Details

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

Key Dates

Start date
Aug 23, 2021
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Control Group
    Given placebo which coincides with the active treatment group

Primary Outcome Measure

Amount of pain medication needed. [ Time Frame: 7 days post-operative or until discharge, whichever came first ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Michaela Canova, BA
[email protected]
916-734-1202
Daniel Neyshloss, BS
[email protected]
916-734-1202
Gary Raff, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UC Davis Medical Center· Sacramento, CA

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