Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 8/18/2018 |
| Start Date: | July 31, 2018 |
| End Date: | December 31, 2018 |
| Contact: | Beena Desai |
| Email: | beena.desai@choa.org |
| Phone: | 404-785-2269 |
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
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.
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.
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.
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.
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
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-2269
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