Preoperative Gabapentin for Post-tonsillectomy Pain in Children

Not Applicable

Completed

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

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
liquid placebo	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
Gabapentin	Gabapentin	gabapentin, 20 mg/kg, single dose, 60 min prior to surgery

Primary Outcome Measures

Name	Time	Method
Total Oral Analgesia Consumption	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 Outcome Measures

Name	Time	Method
Self-report Pain Score at Rest	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.
Self-report Pain Score When Swallowing	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.