Clinical trial NCT01707420: Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Official title: Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
Keywords: pediatric pain
post operative pain
opioids
emergence agitation
preoperative anxiety
pharmacogenomics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Oral Analgesia Consumption
timeFrame: Up to 36 hours
Secondary outcomes:
measure: Self-report Pain Score at Rest
timeFrame: Up to 36 hours
measure: Self-report Pain Score When Swallowing
timeFrame: Up to 36 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Thomas Notides, MD
role: PRINCIPAL_INVESTIGATOR
References: