Preoperative Gabapentin for Post-tonsillectomy Pain in Children

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPost Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
InterventionDrug: Gabapentin
Drug: liquid placebo
PhaseN/A
SponsorUniversity of Colorado, Denver
Responsible PartyUniversity of Colorado, Denver
ClinicalTrials.gov IdentifierNCT01707420
First ReceivedOctober 12, 2012
Last UpdatedMarch 12, 2013
Last verifiedMarch 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 12, 2012
Last Updated DateMarch 12, 2013
Start DateAugust 2012
Estimated Primary Completion DateDecember 2013
Current Primary Outcome MeasuresTotal oral analgesia consumption [Time Frame: 36 hours] [Designated as safety issue: No]Total oral analgesic requirement (mL of hydrocodone/acetaminophen elixir) during the first 36 hours post operatively
Current Secondary Outcome MeasuresSelf-report pain score [Time Frame: 36 hours] [Designated as safety issue: No]Self-report pain scores at rest and with swallowing using Bieri Faces Scale-Revised.

Descriptive Information[ + expand ][ + ]

Brief TitlePreoperative Gabapentin for Post-tonsillectomy Pain in Children
Official TitlePreoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children
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 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 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.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionPost Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
InterventionDrug: Gabapentin
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.
Other Names:
NeurontinDrug: liquid placebo
Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
Study Arm (s)
  • Active Comparator: Gabapentin
    gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
  • Placebo Comparator: liquid placebo
    subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment75
Estimated Completion DateDecember 2013
Estimated Primary Completion DateDecember 2013
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
GenderBoth
Ages5 Years
Accepts Healthy VolunteersNo
ContactsContact: Thomas Notides, MD
720 777-6005
thomas.notides@childrenscolorado.org
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01707420
Other Study ID Numbers11-1687
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Colorado, Denver
Study SponsorUniversity of Colorado, Denver
CollaboratorsNot Provided
Investigators Principal Investigator: Thomas Notides, MD University of Colorado, Denver
Verification DateMarch 2013

Locations[ + expand ][ + ]

Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Thomas Notides, MD | 720-777-6005 | thomas.notides@childrenscolorado.org
Principal Investigator: Thomas Notides, MD
Recruiting