CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
liquid placebo 0.4mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01707420
NCT01707420N/ACompleted

Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children

University of Colorado, Denver·interventional·Posted Oct 16, 2012·Updated Jan 15, 2021

In Brief

A clinical study evaluating Gabapentin and liquid placebo for Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.7 years ago

Interventions

Gabapentindrug

The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.

liquid placebodrug

Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.