Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Children's Healthcare of Atlanta
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this 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.
Eligibility Criteria
Treatment Details
2Treatment groups
Active Control
Placebo Group
Group I: Gabapentin GroupActive Control1 Intervention
Participants will be randomized to either Control Group or Gabapentin Group
Group II: Placebo GroupPlacebo Group1 Intervention
Participants will be randomized to either Control Group or Gabapentin Group
Gabapentin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neurontin for:
- Postherpetic neuralgia
- Partial-onset seizures
🇪🇺 Approved in European Union as Gabapentin for:
- Peripheral neuropathic pain
- Partial-onset seizures
🇨🇦 Approved in Canada as Gabapentin for:
- Postherpetic neuralgia
- Partial-onset seizures
Find a clinic near you
Research locations nearbySelect from list below to view details:
Children's Healthcare of AtlantaAtlanta, GA
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Who is running the clinical trial?
Children's Healthcare of AtlantaLead Sponsor