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Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy | Preoperative Gabapentin for Post-tonsillectomy Pain in Children

Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GabapentinThe 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.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: August 2012

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Total oral analgesia consumption

Secondary Outcome: Self-report pain score

Study sponsors, principal investigator, and references

Principal Investigator: Thomas Notides, MD

Lead Sponsor: University of Colorado, Denver

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01707420

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