Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
Purpose
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.
Conditions
- Tonsillitis
- Tonsillectomy
Eligibility
- Eligible Ages
- Between 3 Years and 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Atlanta 4180439, Georgia 4197000 30329
More Details
- Status
- Recruiting
- Sponsor
- Children's Healthcare of Atlanta
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.