Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Recruitment status was Recruiting
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.
Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
Drug: liquid placebo
|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.
|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)|
Active Comparator: Gabapentin
gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
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
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
Drug: liquid placebo
Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707420
|Contact: Thomas Notides, MD||720 email@example.com|
|Contact: Jeannie Zuk, PhD||720 firstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Thomas Notides, MD 720-777-6005 email@example.com|
|Contact: Jeannie Zuk, PhD 720 777-6690 firstname.lastname@example.org|
|Principal Investigator: Thomas Notides, MD|
|Sub-Investigator: Norah Janosy, MD|
|Principal Investigator:||Thomas Notides, MD||University of Colorado, Denver|