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Completed

NCT Number: NCT01707420

Preoperative Gabapentin for 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 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.

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Key information

Conditions

Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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: Neurontin

liquid placebo

Drug

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

Primary outcomes

  1. Total Oral Analgesia Consumption

    Time frame: Up to 36 hours

    Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.

Secondary outcomes

  1. Self-report Pain Score at Rest

    Time frame: Up to 36 hours

    Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.

  2. Self-report Pain Score When Swallowing

    Time frame: Up to 36 hours

    Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2012
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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