Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
- Registration Number
- NCT03625011
- Lead Sponsor
- Children's Healthcare of Atlanta
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- participants age 3-18 years
- ASA class 1 or 2
- elective Tonsillectomy/Adenoidectomy
- outpatient setting.
- BMI >40kg/m2
- history of renal insufficiency, chronic pain
- allergy to gabapentin
- history of developmental delay
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gabapentin Group Gabapentin Participants will be randomized to either Control Group or Gabapentin Group Placebo Group Gabapentin Participants will be randomized to either Control Group or Gabapentin Group
- Primary Outcome Measures
Name Time Method Narcotic Consumption First 48 hours postoperatively To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m\^2).
- Secondary Outcome Measures
Name Time Method First Analgesic Timing First 48 Hours postoperatively To record the time to first analgesic postoperatively
Pain Scale Scores 12, 24 and 48 hours postoperatively. To compare the Wong- Baker FACES Pain Rating Scale and the 1-10 numeric pain distress scale pain scores at 12, 24 and 48 hours postoperatively. The 0-10 Numeric Pain Distress Pain Scale utilizes number gradations to describe pain for school age children and adolescents. A zero score means the absence of pain while a five describes distressing pain and a ten infers unbearable pain. As for the Wong-Baker FACES Scale, a series of faces can be shown to children over the age of three. The six faces depict facial expressions with zero-no hurt at all, one-hurts just a little bit, two-hurts a little more, three-hurts even more, four-hurts a whole lot, and five- hurts as much as you can imagine. No subscales will be used or combined.
Trial Locations
- Locations (1)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States