Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01707420 |
Other study ID # |
11-1687 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 2012 |
Est. completion date |
December 2015 |
Study information
Verified date |
December 2020 |
Source |
University of Colorado, Denver |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This is a randomized, double blind, placebo-controlled trial to study the effect of a
preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective
pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also
look for a limited set of genotypic variations to explain any difference between individuals
or groups in their response to the medication. Additionally, investigators will document
potential adverse effects including excessive sedation, respiratory issues, surgical bleeding
and emergence agitation/delirium.
Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain
scores up to 36 hours post adenotonsillectomy without increased adverse effects such as
emergence delirium, respiratory complications or bleeding. The clinical effect may depend on
the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms
that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic
pain medications.