Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
Overview
- Phase
- Phase 4
- Intervention
- Gabapentin
- Conditions
- Tonsillitis
- Sponsor
- Children's Healthcare of Atlanta
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Narcotic Consumption
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
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.
Investigators
Margaret Gettis
Nurse Scientist
Children's Healthcare of Atlanta
Eligibility Criteria
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
Arms & Interventions
Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
Intervention: Gabapentin
Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
Intervention: Gabapentin
Outcomes
Primary Outcomes
Narcotic Consumption
Time Frame: 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 Outcomes
- First Analgesic Timing(First 48 Hours postoperatively)
- Pain Scale Scores(12, 24 and 48 hours postoperatively.)