Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 04/30/2016 |
| First Submitted: | 10/11/2012 |
| Estimated Enrollment Submitted: | 10/11/2012 |
| First Posted: | 10/15/2012 |
| Last Update Submitted: | 05/19/2016 |
| Last Update Posted: | 05/22/2016 |
| Actual Study Start Date: | 07/31/2012 |
| Estimated Primary Completion Date: | 11/30/2015 |
| Estimated Study Completion Date: | 11/30/2015 |
Condition or disease
Intervention/treatment
Drug: Gabapentin
Drug: liquid placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Gabapentin gabapentin, 20 mg/kg, single dose, 60 min prior to surgery | 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. |
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 5 Years To 5 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Total oral analgesia consumption [36 hours]
Secondary Outcome Measures
1. Self-report pain score [36 hours]
