Preoperative Gabapentin for Post-tonsillectomy Pain in Children
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 5 - 16 |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | June 2016 |
Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children
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 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.
and adenoids can be challenging, especially for pain control. First line medications for
pain include intravenous and enteral narcotics, acetaminophen and 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.
This is a randomized, double blinded, 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.
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.
Inclusion Criteria:
- scheduled for outpatient tonsillectomy and adenoidectomy
- < 60 Kg, between 5th and 95th percentile for weight
- ability to self-report pain
- complete pain diary with assistance from parent or guardian
Exclusion Criteria:
- require pre-anesthesia medication for anxiety
- require interpreter for verbal or written communication
- Obstructive sleep apnea significant enough to not qualify for outpatient surgery per
surgeon
- ongoing oxygen dependence, pulmonary hypertension
- elevated risk of regurgitation
- history of seizures
- currently taking psychoactive medications or having a psychiatric condition requiring
medications
- chronic pain disorders requiring medications
- renal disease
- developmental or cognitive disabilities
- history of adverse reactions to components of liquid gabapentin or placebo
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