Preoperative Gabapentin for Post-tonsillectomy Pain in Children

Completed · Not applicable · Has a placebo group

Conditions studied: Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy

In brief

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.

Key facts

Study ID

NCT01707420

Run by

University of Colorado, Denver

People needed

36

Starts

2012-08-01

Expected to finish

2015-12-01

Last updated by the study team

2021-01-15

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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