Preoperative Gabapentin for Post-tonsillectomy Pain in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01707420
First received: October 12, 2012
Last updated: March 12, 2013
Last verified: March 2013
  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.


Condition Intervention
Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
Drug: Gabapentin
Drug: liquid placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Total 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


Secondary Outcome Measures:
  • Self-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.


Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707420

Contacts
Contact: Thomas Notides, MD 720 777-6005 thomas.notides@childrenscolorado.org
Contact: Jeannie Zuk, PhD 720 777-6690 jeannie.zuk@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Notides, MD    720-777-6005    thomas.notides@childrenscolorado.org   
Contact: Jeannie Zuk, PhD    720 777-6690    jeannie.zuk@childrenscolorado.org   
Principal Investigator: Thomas Notides, MD         
Sub-Investigator: Norah Janosy, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas Notides, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01707420     History of Changes
Other Study ID Numbers: 11-1687
Study First Received: October 12, 2012
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 16, 2014