RecruitingPhase 4NCT03625011

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial


Sponsor

Children's Healthcare of Atlanta

Enrollment

50 participants

Start Date

Jul 31, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Inclusion Criteria4

  • participants age 3-18 years
  • ASA class 1 or 2
  • elective Tonsillectomy/Adenoidectomy
  • outpatient setting.

Exclusion Criteria4

  • BMI \>40kg/m2
  • history of renal insufficiency, chronic pain
  • allergy to gabapentin
  • history of developmental delay

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Interventions

DRUGGabapentin

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.


Locations(1)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT03625011


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