Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01707420
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2012-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.notides@childrenscolorado.org', 'phone': '720-777-6005', 'title': 'Thomas Notides', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo group', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gabapentin', 'description': 'Gabapentin group', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unplanned admission post tonsillectomy', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Oral Analgesia Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Participants received placebo prior to tonsillectomy'}, {'id': 'OG001', 'title': 'Gabapentin Group', 'description': 'Participants received gabapentin prior to tonsillectomy'}], 'classes': [{'title': 'cumulative hydrocodone (mg/kg) at 36h', 'categories': [{'measurements': [{'value': '0.228', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '0.224', 'spread': '0.165', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 24h', 'categories': [{'measurements': [{'value': '0.200', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '0.193', 'spread': '0.148', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 12h', 'categories': [{'measurements': [{'value': '0.171', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '0.165', 'spread': '0.116', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 8h', 'categories': [{'measurements': [{'value': '0.157', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '0.132', 'spread': '0.086', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 4h', 'categories': [{'measurements': [{'value': '0.135', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.109', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 1.5h', 'categories': [{'measurements': [{'value': '0.127', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 1h', 'categories': [{'measurements': [{'value': '0.121', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.066', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 0.5h', 'categories': [{'measurements': [{'value': '0.107', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.046', 'groupId': 'OG001'}]}]}, {'title': 'cumulative hydrocodone (mg/kg) at 0h', 'categories': [{'measurements': [{'value': '0.079', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 hours', 'description': 'Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.', 'unitOfMeasure': 'cumulative hydrocodone (mg/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy children aged 5 - 16 years old.'}, {'type': 'SECONDARY', 'title': 'Self-report Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'The gabapentin (treatment) group was given gabapentin, at a single dose of 20 mg/kg, 60 min prior to surgery in liquid form of less than 0.4 mL/kg total volume.\n\nThis 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 post-op pain management in healthy pediatric tonsillectomy/adenoidectomy patients.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants randomized to the placebo arm will received a single dose of placebo, an identical appearing mixture of sweetener, thickener, and water of equal volume, also given 60 min prior to surgery.'}], 'classes': [{'title': '0.5 hours', 'categories': [{'measurements': [{'value': '5.33', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': '1.0 hours', 'categories': [{'measurements': [{'value': '4.33', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '5.80', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '3.30', 'groupId': 'OG001'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '3.46', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '3.91', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '2.69', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '3.04', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': '36 hours', 'categories': [{'measurements': [{'value': '1.95', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 hours', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-report Pain Score When Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'The gabapentin (treatment) group was given gabapentin, at a single dose of 20 mg/kg, 60 min prior to surgery in liquid form of less than 0.4 mL/kg total volume.\n\nThis 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 post-op pain management in healthy pediatric tonsillectomy/adenoidectomy patients.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants randomized to the placebo arm will received a single dose of placebo, an identical appearing mixture of sweetener, thickener, and water of equal volume, also given 60 min prior to surgery.'}], 'classes': [{'title': '0.5 Hours', 'categories': [{'measurements': [{'value': '6.47', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '5.42', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': '1 Hours', 'categories': [{'measurements': [{'value': '4.78', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': '1.5 Hours', 'categories': [{'measurements': [{'value': '5.40', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': '4 Hours', 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '3.44', 'groupId': 'OG001'}]}]}, {'title': '8 Hours', 'categories': [{'measurements': [{'value': '5.30', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': '12 Hours', 'categories': [{'measurements': [{'value': '3.86', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '5.46', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '5.65', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': '36 Hours', 'categories': [{'measurements': [{'value': '3.70', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '2.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 hours', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': 'Participants received placebo prior to tonsillectomy'}, {'id': 'FG001', 'title': 'Gabapentin Group', 'description': 'Participants received gabapentin prior to tonsillectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo group'}, {'id': 'BG001', 'title': 'Gabapentin', 'description': 'Gabapentin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Median age (years)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '14'}, {'value': '8.0', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '15'}, {'value': '8.0', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2012-10-12', 'resultsFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-22', 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Oral Analgesia Consumption', 'timeFrame': 'Up to 36 hours', 'description': 'Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.'}], 'secondaryOutcomes': [{'measure': 'Self-report Pain Score at Rest', 'timeFrame': 'Up to 36 hours', 'description': '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.'}, {'measure': 'Self-report Pain Score When Swallowing', 'timeFrame': 'Up to 36 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric pain', 'post operative pain', 'opioids', 'emergence agitation', 'preoperative anxiety', 'pharmacogenomics'], 'conditions': ['Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nInvestigators 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for outpatient tonsillectomy and adenoidectomy\n* \\< 60 Kg, between 5th and 95th percentile for weight\n* ability to self-report pain\n* complete pain diary with assistance from parent or guardian\n\nExclusion Criteria:\n\n* require pre-anesthesia medication for anxiety\n* require interpreter for verbal or written communication\n* Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon\n* ongoing oxygen dependence, pulmonary hypertension\n* elevated risk of regurgitation\n* history of seizures\n* currently taking psychoactive medications or having a psychiatric condition requiring medications\n* chronic pain disorders requiring medications\n* renal disease\n* developmental or cognitive disabilities\n* history of adverse reactions to components of liquid gabapentin or placebo'}, 'identificationModule': {'nctId': 'NCT01707420', 'briefTitle': 'Preoperative Gabapentin for Post-tonsillectomy Pain in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children', 'orgStudyIdInfo': {'id': '11-1687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin', 'description': 'gabapentin, 20 mg/kg, single dose, 60 min prior to surgery', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'liquid placebo', 'description': 'subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery', 'interventionNames': ['Drug: liquid placebo']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': '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.', 'armGroupLabels': ['Gabapentin']}, {'name': 'liquid placebo', 'type': 'DRUG', 'description': 'Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.', 'armGroupLabels': ['liquid placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Thomas Notides, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}