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Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

StatusRecruiting
PhasePhase 4
Started
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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.

Record History

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  1. Primary and study completion dates: Dec 31, 2018 to Dec 31, 2019v3
  2. Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 6 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03625011
Lead Sponsor Children's Healthcare of Atlanta
Conditions
(from sponsor)		 Tonsillitis, Tonsillectomy
Related terms Tonsillitis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov