Preoperative Gabapentin for Post-tonsillectomy Pain in Children
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy |
Drug: Gabapentin Drug: liquid placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children |
- Total oral analgesia consumption [ Time Frame: 36 hours ] [ Designated as safety issue: No ]Total oral analgesic requirement (mL of hydrocodone/acetaminophen elixir) during the first 36 hours post operatively
- Self-report pain score [ Time Frame: 36 hours ] [ Designated as safety issue: No ]Self-report pain scores at rest and with swallowing using Bieri Faces Scale-Revised.
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Gabapentin
gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
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Drug: Gabapentin
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 Name: Neurontin
|
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Placebo Comparator: 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
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Drug: liquid placebo
Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
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Detailed Description:
This is a randomized, double blinded, 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.
Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Thomas Notides, MD | 720 777-6005 | thomas.notides@childrenscolorado.org |
| Contact: Jeannie Zuk, PhD | 720 777-6690 | jeannie.zuk@childrenscolorado.org |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Thomas Notides, MD 720-777-6005 thomas.notides@childrenscolorado.org | |
| Contact: Jeannie Zuk, PhD 720 777-6690 jeannie.zuk@childrenscolorado.org | |
| Principal Investigator: Thomas Notides, MD | |
| Sub-Investigator: Norah Janosy, MD | |
| Principal Investigator: | Thomas Notides, MD | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01707420 History of Changes |
| Other Study ID Numbers: | 11-1687 |
| Study First Received: | October 12, 2012 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Colorado, Denver:
|
pediatric pain post operative pain opioids |
emergence agitation preoperative anxiety pharmacogenomics |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on June 18, 2013