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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 nonsteroidal anti-inflammatory drugs (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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | gabapentin, 20 mg/kg, single dose, 60 min prior to surgery |
|
| liquid placebo | Placebo Comparator | subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Oral Analgesia Consumption | Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively. | Up to 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report Pain Score at Rest | Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Notides, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Participants received placebo prior to tonsillectomy |
| FG001 | Gabapentin Group | Participants received gabapentin prior to tonsillectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo group |
| BG001 | Gabapentin | Gabapentin |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Oral Analgesia Consumption | Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively. | Healthy children aged 5 - 16 years old. | Posted | Mean | Standard Deviation | cumulative hydrocodone (mg/kg) | Up to 36 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo group | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unplanned admission post tonsillectomy | Surgical and medical procedures | Systematic Assessment | Participants were scheduled for outpatient, same-day surgery. We tracked the number of patients from each group that needed to be admitted, unplanned, to the inpatient hospital unit post-op for any reason. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Notides | University of Colorado | 720-777-6005 | thomas.notides@childrenscolorado.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| liquid placebo | Drug | Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg. |
|
| Up to 36 hours |
| Self-report Pain Score When Swallowing | Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op. | Up to 36 hours |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Self-report Pain Score at Rest | Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op. | Posted | Mean | Standard Deviation | score on a scale | Up to 36 hours |
|
|
|
| Secondary | Self-report Pain Score When Swallowing | Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op. | Posted | Mean | Standard Deviation | score on a scale | Up to 36 hours |
|
|
|
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Gabapentin | Gabapentin group | 0 | 18 | 0 | 18 | 9 | 18 |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 1.5 hours |
|
| 4 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| 36 hours |
|
| 1.5 Hours |
|
| 4 Hours |
|
| 8 Hours |
|
| 12 Hours |
|
| 24 Hours |
|
| 36 Hours |
|