Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Recruiting in 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

Inclusion Criteria

participants age 3-18 years

ASA class 1 or 2

elective Tonsillectomy/Adenoidectomy

Participant Groups

Group I: Gabapentin Group Active Control 1 Intervention

Participants will be randomized to either Control Group or Gabapentin Group

Group II: Placebo Group Placebo Group 1 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 Nearby Select from list below to view details:

Children's Healthcare of Atlanta Atlanta, GA

Who Is Running the Clinical Trial?

Children's Healthcare of Atlanta Lead Sponsor

References