Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Children's Healthcare of Atlanta
Study ID
NCT03625011
Phase
PHASE4
Status
Recruiting
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Conditions

  • Tonsillectomy
  • Tonsillitis

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Gabapentin — DRUG
    This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.

Study Details

The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.

Key Dates

Start date
Jul 31, 2018
Status verified
Jul 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Placebo Comparator: Placebo Group
    Participants will be randomized to either Control Group or Gabapentin Group
  • Active Comparator: Gabapentin Group
    Participants will be randomized to either Control Group or Gabapentin Group

Primary Outcome Measure

Narcotic Consumption [ Time Frame: First 48 hours postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30329
Beena Desai
[email protected]
404-785-2269
Margaret A. Gettis, DNP,CPNP-PC
[email protected]
404-785-8622

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Children's Healthcare of Atlanta· Atlanta, GA

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