Preoperative Gabapentin for Post-tonsillectomy Pain in Children
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|ClinicalTrials.gov Identifier: NCT01707420|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy||Drug: Gabapentin Drug: liquid placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- Total oral analgesia consumption [ Time Frame: 36 hours ]Total oral analgesic requirement (mL of hydrocodone/acetaminophen elixir) during the first 36 hours post operatively
- Self-report pain score [ Time Frame: 36 hours ]Self-report pain scores at rest and with swallowing using Bieri Faces Scale-Revised.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707420
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Thomas Notides, MD||University of Colorado, Denver|