Preoperative Gabapentin for Post-tonsillectomy Pain in Children

University of Colorado Denver (CU Denver)

Status: Completed

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

Treatments: Drug: Gabapentin; Drug: liquid placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01707420

11-1687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Gabapentin

Active Comparator group

Description:

gabapentin, 20 mg/kg, single dose, 60 min prior to surgery

Treatment:

Drug: Gabapentin

liquid placebo

Placebo Comparator group

Description:

subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery

Treatment:

Drug: liquid placebo