Clinical Trial

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Recruiting Phase 4
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Record status
This record was last updated July 24, 2019 (before its estimated December 31, 2019 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2018-08-07; most recent amendment 2021-12-06.
Status change: Recruiting → Completed 2021-12-06
Trial Details
NCT Number NCT03625011
Lead Sponsor Children's Healthcare of Atlanta
Conditions Tonsillitis, Tonsillectomy
Enrollment 50 participants
Start Date 2018-07-31
Primary Completion 2019-12-31 (estimated)
Study Completion 2019-12-31 (estimated)
Updated on ClinicalTrials.gov 2019-07-24