Preoperative Gabapentin for Post-tonsillectomy Pain in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707420
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 23, 2016
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy Drug: Gabapentin Drug: liquid placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arm Intervention/treatment
Active Comparator: Gabapentin
gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
Drug: 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 Name: Neurontin

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

Primary Outcome Measures :
  1. Total oral analgesia consumption [ Time Frame: 36 hours ]
    Total oral analgesic requirement (mL of hydrocodone/acetaminophen elixir) during the first 36 hours post operatively

Secondary Outcome Measures :
  1. Self-report pain score [ Time Frame: 36 hours ]
    Self-report pain scores at rest and with swallowing using Bieri Faces Scale-Revised.

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707420

United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Thomas Notides, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT01707420     History of Changes
Other Study ID Numbers: 11-1687
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by University of Colorado, Denver:
pediatric pain
post operative pain
emergence agitation
preoperative anxiety

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents