Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Children's Healthcare of Atlanta

Status and phase: Enrolling; Phase 4

Conditions: Tonsillectomy; Tonsillitis

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03625011

IRB 18-052

Details and patient eligibility

About

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.

Full description

This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As from a regional healthcare organization. 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. Additionally, young children will receive instruction for Tylenol and Motrin postoperatively while teenagers will receive a narcotic prescription. Outcome measurements include: mean Tylenol mg/kg, Motrin mg/kg and narcotic mg/kg use. Additional measurements: Mean time to first analgesic. Phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Participants will be randomized to either Control Group or Gabapentin Group

Treatment:

Drug: Gabapentin

Gabapentin Group

Active Comparator group

Description:

Participants will be randomized to either Control Group or Gabapentin Group

Treatment:

Drug: Gabapentin