Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Overview[ - collapse ][ - ]
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. |
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Condition | Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy |
Intervention | Drug: Gabapentin Drug: liquid placebo |
Phase | N/A |
Sponsor | University of Colorado, Denver |
Responsible Party | University of Colorado, Denver |
ClinicalTrials.gov Identifier | NCT01707420 |
First Received | October 12, 2012 |
Last Updated | March 12, 2013 |
Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 12, 2012 |
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Last Updated Date | March 12, 2013 |
Start Date | August 2012 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | 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 |
Current Secondary Outcome Measures | 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. |
Descriptive Information[ + expand ][ + ]
Brief Title | Preoperative Gabapentin for Post-tonsillectomy Pain in Children |
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Official Title | Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children |
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 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 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy |
Intervention | 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 Names: NeurontinDrug: liquid placebo Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 75 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | December 2013 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 5 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Thomas Notides, MD 720 777-6005 thomas.notides@childrenscolorado.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01707420 |
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Other Study ID Numbers | 11-1687 |
Has Data Monitoring Committee | No |
Information Provided By | University of Colorado, Denver |
Study Sponsor | University of Colorado, Denver |
Collaborators | Not Provided |
Investigators | Principal Investigator: Thomas Notides, MD University of Colorado, Denver |
Verification Date | March 2013 |
Locations[ + expand ][ + ]
Children's Hospital Colorado | Aurora, Colorado, United States, 80045 Contact: Thomas Notides, MD | 720-777-6005 | thomas.notides@childrenscolorado.orgPrincipal Investigator: Thomas Notides, MD Recruiting |
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